Guidelines on the Prevention, Detection, And Management of Clostridium difficile Infection

Transcription

1 Guidelines on the Prevention, Detection, And Management of Clostridium difficile Infection 1

2 CLINICAL GUIDELINES CHECKLIST Name of guidelines Guidelines on the Prevention, Detection, and Management of Clostridium difficile Infection Purpose of guideline The aim of this guidance is to prevent, diagnose, control and treat Clostridium difficile infection (CDI) within the Southern Heath & Social Care Trust. This guidance should be used to enable staff to deliver safe healthcare to support the reduction of CDI. Managers are responsible for ensuring staff are aware of this guideline and comply with all aspects but with particular reference to: Prompt diagnosis and isolation of patients, as per the Trust Guidance (link to isolation) Implementation of infection prevention & control precautions including hand hygiene Cleaning of the environment and equipment Antibiotic stewardship Managers are also responsible for ensuring staff have adequate supplies of equipment, particularly consumables to ensure compliance with this guidance. Director responsible Medical Director Name and title of author Reviewed by:- Infection prevention & Control Team Dr Martin Brown Consultant Microbiologist Mr Colin Clarke Lead Infection Prevention & Control Nurse and SHSCT Infection prevention & Control Nurses Date: 26 th May, 2015 Consulted upon: Approved by: Review Date (Every 2 years or sooner if required): Yes Southern Health & Social Care Trust Clinical Forum August 2019; and if significant new evidence or other implications for practice are published. CG0577 2

3 Contents 1) Background to Clostridium difficile..4 2) Guidance on interpretation of Clostridium difficile testing...8 3) Diagnosis of Clostridium difficile diarrhoea..10 4) Treatment of Clostridium difficile induced diarrhoea and colitis ) Management of a patient with Clostridium difficile Infection (CDI)..16 6) CDI infection prevention & control measures..18 7) Environmental cleaning and decontamination of equipment 26 8) Forms.27 a) Applied Bristol Stool Chart b) Daily assessment sheet for patient with CDI.29 c) C. diff care bundle audit 30 d) C. diff positive patient contact list 31 e) Actichlor Plus dilution chart 32 9) References 33 3

4 1.0 Background to Clostridium difficile Diarrhoea is a common side effect of treatment with antibacterial drugs. It is particularly associated with broad spectrum antibiotics which are effective against a range of different bacteria. Antibiotic-associated diarrhoea is often mild and resolves spontaneously when the antibiotic is stopped. Infection with C. difficile is the cause of about 20% of antibioticassociated diarrhoea The clinical spectrum of CDI can vary from asymptomatic carriage to life-threatening disease. The risk of Clostridium difficile infection There are four requirements for CDI Exposure to the C. difficile bacterium Treatment with antibiotics Toxins produced by the C. difficile bacterium Susceptible people. These will be discussed in this document. 1.1 Exposure to Clostridium difficile C. difficile is ubiquitous and is widely distributed in the environment, particularly in soil and in healthcare facilities. It survives in hostile environments by forming spores. The organisms go into a dormant state and are enclosed by a shell-like coat that is resistant to many measures that normally kill bacteria, including heat, cold, ultraviolet light, alcohol and many disinfectants. C. difficile is common in the intestine of babies, but does not cause illness in them. It can also be found in low numbers in the intestine of a small proportion (less than 5%) of the healthy adult population. Spores can be removed by thorough hand washing in soap and running water. The only commonly used disinfectant that kills Clostridia spores is hypochlorite (bleach), which, because of its toxicity, must be used with care. 1.2 Clostridium difficile infection and antibiotics Previous antibiotic use is the predominant risk factor for C. difficile acquisition. The adult human large bowel contains trillions of bacteria of many different species. The proportions of different species vary among individuals but remain relatively constant for any one individual throughout his or her lifetime. The species are normally in balance, and while this balance is maintained, the bacteria are harmless or even, in some cases, beneficial. If the balance is disturbed, harmful effects can occur, ranging from mild diarrhoea to severe damage to the large bowel and other organs, with serious or even fatal effects. The balance of organisms in the large bowel may be disturbed by treatment with antibiotics as some of the organisms will be sensitive to the drug and be killed, while others will be resistant and survive. In the absence of the competing organisms, the survivors can grow ( overgrow ) in the bowel and, depending on the species concerned, may have harmful effects. 4

5 If antibiotics that kill some of the bacteria in the bowel but do not kill C. difficile are taken, overgrowth of any C. difficile present can occur, or the space created can be filled by C. difficile that has been introduced to the mouth by hands contaminated with the spores. The number of antibiotics implicated in causing CDI is growing. The sensitivity of organisms, including C. difficile, to antibiotics is continually evolving and it is impossible to predict the effects of antibiotics in new outbreaks of CDI. Both appropriate and inappropriate antibiotic prescribing may lead to cases of CDI. In many cases the drugs have been appropriately prescribed for the treatment of serious or even lifethreatening conditions. Careful prescribing of antibiotics, such as avoiding certain types of antibiotics, and stopping antibiotics when they are no longer required, is important in reducing CDI in hospitals and nursing homes. The balance of risk between the possibility of CDI from the antibiotic and the serious infection for which the drug is the only treatment must always be assessed. People who have not recently taken antibiotics are not at risk of developing CDI even if they have been close to an affected patient. Personal hygiene, particularly hand washing, reduces the risk of any further transmission. Because of its relationship with treatment with antibiotics, CDI is classified as a healthcare acquired infection (HCAI). 1.3 Clostridium difficile toxins In susceptible people who are taking antibiotics, CDI develops after oral ingestion of C difficile spores from contaminated hands or, in a minority, from C difficile already in the bowel. The spores are unaffected by the acid in the stomach and travel to the large bowel, where the organism assumes its active state and is able to proliferate and produce its toxins harmful chemicals that affect specific parts of the human body. C difficile produces two toxins, labelled A and B, which have different but complementary effects on the lining of the large bowel (colon), producing inflammation and tissue damage and resulting in diarrhoea and other clinical features. CDI is diagnosed by testing for the toxins in a specimen of liquid faeces. This test is available in hospital laboratories. In cases of diarrhoea, it is usually combined with tests for other infections that commonly cause diarrhoea as a diarrhoea screen. This occasionally results in a diagnosis of CDI when it was not clinically suspected. 1.4 Susceptibility to Clostridium difficile infection CDI occurs most often in frail older people who have multiple illnesses and disabilities and who may be close to the end of their lives. Older people have a lower resistance to infections and are more likely to have other serious diseases when the infection occurs. They are also more likely to be treated with antibiotics, most commonly for respiratory or urinary tract infections. CDI may not cause or contribute to their deaths, but if it does, the occurrence of this most unpleasant illness may rob them of the opportunity to end their lives in comfort and dignity, in a place of their choosing, and surrounded by those they are close to. CDI can occur in younger people, and fatalities have been reported in people as young as 30 years of age. Younger people with reduced resistance to infections from disease or 5

6 medications affecting the immune system are most at risk of CDI. CDI does not occur in babies and is very rare in young children. 1.5 Ribotypes C difficile has a number of sub-types, known as ribotypes, with more than 100 having been identified. It is likely that at least some ribotypes in turn have sub-types. The ribotypes differ in the severity of disease that they cause and their sensitivity to antibiotics. Ribotype 027 has recently caused outbreaks of CDI in healthcare settings in North America, Great Britain and elsewhere, and was first identified in Northern Ireland in the outbreak in hospitals in the Northern Health and Social Care Trust. 1.6 Ribotypes associated with more severe disease A strain of 027 has emerged in outbreaks in Northern Ireland. This strain is considered to be more virulent than other strains and produces higher levels of toxins. 027 strains sporulate four times more than the average C. difficile; and is not as responsive to 1 st line C. difficile treatment. The course of infection is more severe and results in more complications. It is associated with a higher risk of relapse and mortality. Other Ribotypes, including 078, have been also been associated with increased severity in disease 1.7 Major risk factors for CDI: Certain patients are at increased risk of acquiring Clostridium difficile infection (CDI). The possibility of CDI should be considered when patients with diarrhoea also have: Current or recent use of antimicrobial agents Increased age over 65yrs Prolonged hospital stay Serious underlying diseases Surgical procedures (in particular bowel procedures) Immunocompromising conditions especially patients on cancer chemotherapy Use of proton pump inhibitors 1.8 Clinical picture The clinical picture in C. difficile infection may vary from mild diarrhoea through to the fulminant life-threatening pseudomembranous colitis and in some cases has lead to death. Symptoms may start as early as day one of antibiotic use or even up to 4-8 weeks after discontinuation of antibiotics. Most antibiotics have been implicated in the development of C. difficile infection but those most commonly associated are Cephalosporins, Quinolones Clindamycin and broad-spectrum penicillin s (e.g. co amoxiclav) Antibiotic stewardship is the key intervention to minimise the development of C. difficile infections. 6

7 1.9 Transmission of C. difficile C difficile is transmitted via spores that are secreted by patients with C. difficile infection leading to contamination of the environment surrounding the symptomatic patient. The spores can survive in the surrounding environment for long periods of time and are resistant to most commonly used disinfectants. These spores are also resistant to alcohol and acids in the stomach, hence using alcohol gel for hand hygiene will not prevent transmission. For those not in the <5% category of the healthy adult population that carry C. difficile normally, C. difficile spores must be ingested for a person to become colonised and subsequently develop a CDI. Transmission is generally via the hands of staff, direct contact with affected patients or contaminated surfaces in the ward (e.g. bathrooms, furniture, bed sheets, commodes, and patient wash bowls). Transmission based infection prevention & control precautions are therefore an important aspect of patient management. 2.0 Guidance on interpretation of Clostridium difficile testing 2.1 Background to testing for CDI The UK Dept. of Health published guidance on C. difficile infection (CDI) testing in March 2012 recommending that combining two types of tests will deliver the most accurate results for CDI testing. As a result, from 1st June 2012, we have introduced a combination of three tests for diagnosing and reporting Clostridium difficile infection (CDI) as a part of HPA regional requirement. 2.2 Asymptomatic C. difficile carriage Up to 5% of healthy individuals have C. difficile carriage in their large bowel. The asymptomatic carriage rate is very high (up to 70%) in neonates and children up to 2 years of age, hence routine testing is not recommended in these population groups. Around 20% of individuals with multiple co-morbidities and frequent exposure to healthcare facilities (i.e. elderly population and young patients with co-morbidity) have C. difficile present in their large bowel resulting in a higher incidence of CDI in this group of patients. 2.3 C. difficile infection (CDI) It is important to note that C. difficile can reside in the large bowel of healthy individuals without symptoms; hence the presence of bacteria alone does not constitute a diagnosis of CDI. The diarrhoeal disease is toxin-mediated so laboratory diagnosis relies on demonstrating the presence of toxin(s) produced by C. difficile. 7

8 2.4 SHSCT test method and interpretation. 1. Glutamate dehydrogenase (GDH): This test detects the presence of glutamate dehydrogenase enzyme and a positive result indicates the presence of C. difficile bacteria, but does not indicate whether the bacteria is producing toxin or not. 2. Enzyme Immunoassay (EIA) Test: This test detects the presence of toxins A & B but is not 100% sensitive or 100% specific i.e. false negative and false positive results may occur. The rate of false negatives is sufficiently high that this test, formally the gold standard, is no longer deemed suitable as a stand alone test for the diagnosis of CDI or detection of Clostridium difficile. The detection of toxin however remains significantly associated with a poorer clinical outcome. 3. Polymerase Chain Reaction (PCR): This test is used to confirm the presence of potentially toxigenic Clostridium difficile. It looks for the genes for toxin production. It is only performed on stool samples that are GDH positive. If positive it indicates the presence of C.difficile capable of producing toxin but only a positive Enzyme Immunoassay Test can prove the actual production and presence of toxin. 8

9 Algorithm for Management of a Patient with Unexplained Diarrhoea Suspected Clostridium difficile infection (CDI) If a patient has diarrhoea (Applied Bristol Stool Chart 5-7) that is not clearly attributable to an underlying condition (e.g. inflammatory colitis, overflow) or therapy (e.g. laxatives, enteral feeding) then it is necessary to determine if this is due to CDI. If in doubt please seek advice. This pathway relates to the diagnosis of CDI. Patients should be considered for treatment of CDI before test results are available, particularly if symptoms/signs indicate severe infection. Patients with suspected infectious diarrhoea should be isolated to prevent the transmission of C.difficile, norovirus or other transmissible pathogens. Isolate patient in a single room and implement contact IPC precautions as per Trust guideline which are available on the intranet. If unable to isolate within 2 hours escalate the problem. Collect stool specimen and send it to microbiology. In order for the specimen to be processed for C.difficile the sample must take the shape of the container. Samples should ideally be at least ¼ filled (to indicate diarrhoea). Diarrhoeal samples are tested in the laboratory for C.difficile from:- Hospital patients aged 2 years Community patients aged 65 years Community patients aged < 65 years whenever clinically indicated Interpretation of Result of Sample GDH positive, Toxin positive, PCR positive CDI likely to be present Refer to the Trust guideline for the management of CDI Cases should be discussed on diagnosis with the microbiologist and IPCN Inform patient, relative/carer of test result and inform GP of result on discharge letter GDH positive, Toxin negative, Positive PCR Toxigenic C.difficile present, CDI may be present Needs clinical assessment and consideration of other causes of diarrhoea as well as CDI. Cases should be discussed with the microbiologist where there is a clinical suspicion of CDI. Inform IPCN and patient, relative/carer of test result and inform GP of result on discharge letter. Continue single room isolation and other measures to reduce risk of CDI. GDH positive, Toxin negative, Negative PCR Toxigenic C.difficile not present in sample Consider other causes of diarrhoea GDH negative, Toxin negative C.difficile not present in sample Consider Infection other prevention causes of and diarrhoea; Control Department if non infective may consider ending source isolation Routine Reviewed repeat Date testing April 2015 is not advised. Negative predictive value is 98.9%. If strong clinical suspicion persists discuss with the microbiologist. 9

10 S I G H T Remember the SIGHT list Suspect that a case may be infective when there is no clear alternative cause for diarrhoea Isolate the patient within 2 hours Gloves and apron must be used for all contacts with the patient and their environment Hand washing with soap and water should be carried out before and after each contact with the patient and the patient s environment Test the stool for C.difficile by sending a specimen immediately 3.0 Diagnosis of Clostridium difficile diarrhoea a) Early diagnosis is essential for preventing and controlling Clostridium difficile Infection (CDI) in the healthcare setting. b) When a patient presents with diarrhoea consideration should be given to the possible causes for the diarrhoea (e.g. medication, underlying disease) prior to the submission of a stool specimen. c) DOH guidance on Clostridium difficile says that only diarrhoea (Bristol Stool Chart 5-7) that is not clearly attributable to an underlying condition (e.g. inflammatory colitis, overflow) or therapy (e.g. laxatives, enteral feeding) should be sampled. Stool samples from patients who have received new stimulant laxatives or faecal softeners (e.g. Laxido) in the previous 48 hours should be discussed with the patient s consultant or if unavailable the most senior available doctor before being sent. d) Attention should be paid to the patient s normal bowel habitus. This is especially important with regard to type 5 specimens. e) When a patient has unexplained diarrhoea the patient s doctor must be informed and the patient must be clinically assessed to determine whether Clostridium difficile or other causes of infectious diarrhoea are part of the differential diagnosis. f) The current primary care definition of diarrhoea is 3 or more episodes a day <14 days apart and the sample takes the shape of the container. Conversely though DOH guidelines say that in the healthcare setting a single episode of unexplained diarrhoea is reasonable to use as a threshold to initiate isolation and testing for CDI. Clinical assessment is critical in all circumstances. In the SHSCT it would be at least advised that any patient having 2 or more episodes of unexplained diarrhoea should have a sample of stools sent for testing. g) Any patient suspected of having CDI (or any other cause of infectious diarrhoea) must be isolated and placed under contact precautions. The sending of a sample looking for Clostridium difficile testing implies a clinical suspicion of CDI and an absolute responsibility to manage the patient accordingly and to take steps to prevent the spread of Clostridium difficile. 10

11 3.1 Sampling a) All stools submitted from hospital patients 2 years, that take the shape of the container will be routinely tested for Clostridium difficile, i.e. even if C. difficile is not specifically requested on the form. b) All stools submitted from community patients aged 65 years that take the shape of the container will be routinely tested for Clostridium difficile, i.e. even if C. difficile is not specifically requested on the form. Stools from community patients aged < 65 years will only be tested for Clostridium difficile where this is specifically requested on the form. c) Generally it is not advisable to test for C. difficile from children under the age of two in whom toxigenic strains of C. difficile toxins A & B may be present in the absence of symptoms. d) If a repeat faecal specimen is sent within 28 days of a positive C. difficile result it will not be routinely tested for C. difficile. Discuss with IPCT if this is required. e) Stools not taking the shape of the container will not be processed for C. difficile testing even if this is specifically requested unless this has previously been discussed and agreed with the IPCT. f) All relevant clinical history and the antibiotics the patient has been prescribed should be written on the microbiology request form. g) Stool samples should reach the laboratory as soon as possible after collection. The toxin biodegrades at room temperature (increasing the possibility of false negative results) and hence samples should be stored in the laboratory refrigerator at 4 C if there is a delay in testing. h) In suspected cases of CDI, if the first stool sample is GDH positive and toxin negative continue to isolate patient and apply contact IPC precautions as per Trust guideline. Reassess the patient and if symptoms persist consider treatment for CDI. i) Do NOT retest C. difficile GDH positive and toxin (CDT) positive cases within a period of 28 days (4 weeks) even if the patient is still symptomatic. j) If symptoms resolve and then reoccur after 28 days from the initial infection, recurrent CDI is a possibility. All such cases should be discussed with the medical microbiologist and notified to the infection prevention and control team. A variable proportion of recurrences are reinfections (20-50%). After a first recurrence the risk of another infection increases to 45-60%. k) In suspected cases of silent CDI, such as ileus, toxic megacolon or pseudomembranous colitis without diarrhoea, other diagnostic procedures may be required, such as 1) Colonoscopy 2) Serum creatinine 3) White cell count 4) Abdominal computerised tomography, potentially with referral to a gastroenterologists or gastrointestinal surgeon 11

12 4.0 Treatment of Clostridium difficile induced diarrhoea and colitis a) Some patients may be asymptomatic carriers of Clostridium difficile. No additional antimicrobial treatment may be necessary if the stools have become formed and the patient is well. Patients who are toxin positive however should be viewed as likely to have Clostridium difficile infection. b) Commence the patient on the appropriate antibiotic therapy for C. difficile infection in accordance with the severity of the symptoms. Treatment should be initiated as soon as possible once the diagnosis is made. c) Where there is high clinical suspicion of Clostridium difficile (e.g. due to past history, strongly suggestive clinical features, etc.) treatment should be considered prior to laboratory confirmation, especially if symptoms/signs indicate severe infection. d) Antibiotic prescriptions for other infections should be critically reviewed and should be stopped if possible. If it is not possible to stop these antibiotics, consider altering the regimen to use antibiotics with a lower risk of exacerbating C.difficile infection; the reason for this decision must be clearly documented. Consult a Medical Microbiologist for advice. e) Other medications that may cause diarrhoea should be reviewed. f) Discontinue anti-peristaltic agents (opioids, anti-diarrhoeal agents etc.) g) Discontinue promotility/prokinetic agents (laxatives, stool bulking agents etc.) h) Review the use of proton pump inhibitors and discontinue if possible. i) CDI should be managed as a diagnosis in its own right, with each patient reviewed daily regarding I. Severity of infection II. Fluid resuscitation, III. Electrolyte replacement IV. Nutrition review 12

13 4.1 Antimicrobial treatment of Clostridium difficile induced diarrhoea and colitis. Severity of Disease Management Antibiotics to be administered within 2 hours of diagnosis or 1 hour if septic Asymptomatic carriage Specific treatment not indicated. Mild Disease Simple colitis with watery diarrhoea with lower abdominal colic. Three or fewer stools type 5-7 on Applied Bristol Chart per day and Normal white cell count (WCC). Oral Metronidazole 400 mg 8-hourly for days. Moderate Disease Watery diarrhoea with lower abdominal colic. 3-5 stools of type 5-7 on Applied Bristol Chart per day and Raised WCC < 15,000 Oral Metronidazole 400 mg 8-hourly for days. Severe Disease Severe colitis ± pseudomembrane formation. Severe diarrhoea with abdominal pain, distension, constitutional upset, Leucocytosis WCC >15,000 or leucopenia or Temperature of >38.5 C or Acute rising serum creatinine (e.g. >50% increase above baseline) or Evidence of severe colitis (abdominal or radiological signs). Note: The number of stools may be a less reliable indicator of severity. Oral Vancomycin 125 mg 6-hourly for days +/- IV Metronidazole 500 mg 8-hourly. If a patient has swallowing difficulties/enteral tube give oral solution via naso-gastric tube from reconstitution of Vancomycin injection. The injection can be diluted with 30mls water for injection and given enterally. When used for the oral route the reconstituted injection can be stored in fridge (2-8 )for 24hours. (Please flush naso-gastric tube after administration of the reconstituted Vancomycin) Fidaxomicin 200mg 12-hourly for 10 days should be considered for patients with severe CDI who are considered at high risk for recurrence. All patients for whom fidaxomicin is being considered must be discussed 13

14 with microbiology. If not settling seek advice from microbiologist. Life Threatening Disease Fulminant colitis Severely ill with marked systemic upset, distended tender abdomen ± peritonism, hypotension or Partial or complete ileus or toxic megacolon or CT evidence of severe disease Diarrhoea may be absent. Such patients should be monitored with serum lactate, and colectomy considered especially if caecal dilatation is >10 cm. Colectomy is best performed before serum lactate rises >5 mmol/l. Emergency surgery is required for patients with perforation and those who fail to respond to medical treatment. Urgent surgical referral should be considered in cases of severe/or fulminant colitis. Oral Vancomycin up to 500 mg 6-hourly for days via naso-gastric tube plus IV Metronidazole 500 mg 8-hourly. Give oral solution from reconstitution of Vancomycin injection. The injection can be diluted with 30mls water for injection and given enterally. When used for the oral route the reconstituted injection can be stored in a fridge (2-8 ) for 24hours (Please flush the naso-gastric tube after administration of the reconstituted Vancomycin) Seek advice from microbiologist. If PO / NG Route Not Available Intracolonic vancomycin (500 mg in ml saline 4 12-hourly) should be given as retention enema with iv metronidazole. Intracolonic vancomycin is given via a 18 gauge Foley catheter with 30 ml balloon inserted per rectum; vancomycin instilled; catheter clamped for 60 minutes; deflate and remove. 14

15 4.2 Treatment of mild to moderately severe C. difficile diarrhoea and colitis Mild CDI is not associated with a raised white blood cell count (WBC); it is typically associated with mild diarrhoea (less than 3 loose or liquid stools per day or more frequently than is normal for the person) and no systemic symptoms. Moderate CDI is associated with a raised WBC that is <15 cell/mm3; it is typically associated with moderate diarrhoea (typically 3 or more loose or liquid stools per day or more frequently than is normal for the person) Severe CDI associated with markers of severity, e.g. temperature > 38.5 C, WBC > 15 cells/mm3, creatinine > 1.5 x baseline, etc. Life-threatening CDI includes hypotension, partial or complete ileus or toxic megacolon, or CT evidence of severe disease. 4.3 Vancomycin therapy should be used in patients: - Who have failed to respond to 7 days of oral Metronidazole therapy - Critically ill patients - Severe CDI - Cases of pseudomembranous colitis - Unable to tolerate Metronidazole - Pregnant - Where the infecting organism is 027 strain 4.4 Treatment of recurrent/relapsed C. difficile infection Recurrent symptoms likely to develop in about 20% of cases. This most commonly occurs 5-20 days after primary illness but can occur up to 6 weeks later. Symptoms can be due to re-infection with different strain of C. difficile. 15

16 Please refer to a Medical Microbiologist for management of recurrent or complicated cases. 4.5 Other regimens for treatments for CDI (These treatments must only be used after discussion with a medical microbiologist) i. Immunotherapy: Normal human immunoglobulin 400mg/kg stat IV. A further dose may be considered 7-14 days later. NOTE: Human immunoglobulin is reserved for cases where symptoms are severe or where they have relapsed on two or more occasions. ii. iii. iv. Probiotics: The use of probiotics in c difficile infection remains controversial Meta-analyses have usually failed to demonstrate statistically significant efficacy in treating or preventing CDI. The role or probiotics in the prevention of CDI has been under-explored but at present they are not recommended for widespread use for the prevention of CDI. The opinion of the consultant medical microbiologist should be sought before consideration of such therapy. Saccharomyces boulardii: This has been studied extensively but with conflicting results. It is not licensed for use in the United Kingdom and is not recommended. Cases of fungaemia have been reported with it even in immunocompetent patients. Toxin adsorbents: There is no robust evidence to support the use of cholestyramine and it may bind antibiotics used to treat CDI. It is not recommended. v. Non-toxigenic C. difficile: Still undergoing trials. Not currently recommended. vi. vii. viii. ix. Faecal transplant: The first RCT suggested this treatment was efficacious however a cost-effectiveness evaluation has not been performed. Fusidic acid: Some evidence of efficacy but not a first line agent. Development of resistance likely to limit use in recurrences. Rifampicin: Limited evidence base. The addition of oral rifampicin 300mg bd may be considered in severe cases that are not responding to Vancomycin. Rifaximin: Limited evidence. Not currently recommended. x. Tapered-pulsed Vancomycin: o Oral Vancomycin 125 mg qds for 7 days, then o Oral Vancomycin 125 mg tds for 7 days then o Oral Vancomycin 125 mg bd. for 7 days, then o Oral Vancomycin 125 mg od. for 7 days, then o Oral Vancomycin 125 mg daily alternate days for 1 week o Oral Vancomycin 125mg every third day for one week 4.6 Surgical treatment 16

17 Patients with clinical features indicative of likely 027 type infection and/or evidence of pseudomembranous colitis will need urgent surgical referral (refer to 6.5). Colectomy must be considered, as it may be life-saving, and advantages vs. disadvantages assessed based on a surgical opinion 5.0 Management of a patient with Clostridium difficile Infection 5.1 Clinical suspicion of CDI a) The patient with suspected or confirmed CDI should be nursed in a single room preferably with en suite toilet facilities. This should be initiated no later than 2 hours after the onset of symptoms. b) Record the time the patient was relocated into a single room in the patient s nursing notes and on the C. difficile daily care bundle. c) Where there is high clinical suspicion of C. difficile (e.g. due to past history, strongly suggestive clinical features, etc.) treatment may be initiated prior to confirmation. 5.2 Confirmation of positive C. difficile result a) The laboratory staff will immediately inform the ward, by phone, of the C. difficile positive result (GDH positive and Toxin positive). The ward will be informed of cases which are GDH positive, toxin negative and PCR positive. b) The ward manager must inform the patient s consultant, head of service/lead nurse and infection prevention and control of the positive C. difficile result. 5.3 Root Cause Analysis (RCA) and Incident at ward level. C difficile Root Cause Analysis Procedure which is described on the Trust intranet. Root Cause Analysis will be carried out using Trust s RCA form which can be found on the Trust intranet. 5.4 Incident Reporting of CDI on Datix The Datix must be completed by the clinical team for all newly diagnosed Clostridium difficile positive patients The Datix should be completed within two working days of the confirmed positive C difficile result. 5.5 Monitoring the severity of infection 17

18 a) Monitor for signs of increasing severity of disease, with early referral to the Medical Team and Medical Microbiologist as patients may deteriorate very rapidly. b) The frequency and severity of bowel motions must be recorded on the Applied Bristol Stool Chart to assist in assessing and monitoring the severity of symptoms and condition. c) The Applied Bristol Stool Chart should be recorded each time the patient uses the toilet or commode and it should note if a patient does or does not have a bowel movement. d) The modified early warning system observations (MEWS) should be recorded in accordance with severity of symptoms and at least 6 hourly. e) The medical team responsible for the patient must assess the patient daily recording their findings on the daily assessment sheet. 5.6 Nutrition review - Fluid resuscitation and Electrolyte replacement a) Appropriate fluid and electrolyte replacement is a vital component of general treatment. A daily fluid balance chart must be recorded accurately. b) Consider referring the patient to the dietician for a nutritional review particularly if they are on nil orally, peg feeding, or if they require additional nutritional support. 5.7 Patient/Relative/GP information a) Medical staff should inform the patient and, if the patient agrees, their close relatives of the confirmed Clostridium difficile positive result. This information should include facts about - C. difficile infection - the proposed treatment - the likely course of the disease - the relative importance of CDI in relation to the patient s other health problems - personal hygiene precautions including laundering of patient clothing and the risk of infecting others. - A C. difficile information leaflet reinforcing this information and a laundry advice leaflet should be left with the patient/relative. - A record of these communications (verbal communication and the information leaflets given) should be documented in the patient s medical notes. b) The consultant in charge of the patient has overall responsibility to ensure that relatives have reasonable access to fully informed medical staff. c) The patient and their relatives should be provided with regular updates on their progress by both medical and nursing staff. d) In an effort to assess the patient journey and their experience post C. difficile infection diagnosis, an IPCN will engage with the patient and / or their family and review. This engagement will only proceed after the patient has been informed of their CDI diagnosis. 18

19 e) The clinician should inform the patient s GP at discharge of C. difficile infection or carriage. 6.0 CDI Infection Prevention & Control Measures 6.1 Clinical suspicion of CDI a) The patient with suspected or confirmed CDI should be nursed in a single room preferably with en suite toilet facilities. This should be initiated no later than 2 hours after the onset of symptoms. b) Record the time the patient was relocated into a single room in the patient s nursing notes and on the C. difficile daily care bundle. c) Where there is high clinical suspicion of C. difficile (e.g. due to past history, strongly suggestive clinical features, etc.) treatment may be initiated prior to confirmation. 6.2 Transmission based infection prevention and control precautions a) Standard and contact infection prevention & control precautions should be implemented. b) The ward manager or Nurse in Charge is responsible for completing the daily C. difficile care bundle sheet. c) Clinical team must ensure the daily assessment sheet is completed. 19

20 6.3 Patient Isolation a) Patients with a CDI must be nursed in a single room preferably with an en suite toilet facility. b) Patients presenting in ED with suspected or a known history of CDI should be isolated in a single room preferably with an en suite toilet facility. All patients for admission to hospital via ED must be assessed for CDI and managed accordingly. c) A Source Isolation sign should be clearly displayed on the door of the single room and the door closed. d) Staff must take care, as far as is practical, to ensure feelings of isolation, loneliness and/or stigma are prevented. e) Nursing staff must advise the patient and their visitors of the IPC measures in place. f) If a symptomatic patient has vacated a bed space in a bay, this bay area and the associated toilet facilities, if applicable, require a terminal clean. Staff should compile a contact list of those patients in the bay during the time the patient was symptomatic. This should detail the patient name, health care number and consultant. 6.4 Alert Notices a) The Patient s medical notes must be flagged using the Clostridium difficile and Alert stickers. If these are not flagged please advise a member of the IPCT. b) The patient s Clostridium difficile status will also be flagged electronically on PAS, NIRAES and IMMIX. c) A C difficile alert sticker will be placed in the medical notes advising the clinical team of the positive result and the communications actions. 6.5 Hand Washing a) Meticulous hand washing using soap and water is essential Alcohol hand rub/gels are not recommended as these are not effective in killing the C. difficile spores. Hands should be thoroughly washed in accordance with the World Health Organisation s (WHO s) 5 moments for hand hygiene. In augmented care areas, when working with C difficile positive patients and their equipment - hand washing should be used in the first instance and this followed by the use of alcohol hand rub in accordance with local guidance. 20

21 6.6 Personal Protective Equipment (PPE) a) Staff must wear aprons and gloves for any direct contact with the patient/their immediate environment. Apron and gloves should be removed immediately after contact and disposed of as clinical waste Staff uniforms should be changed on a daily basis. 6.7 Patient s Personal Hygiene a) Staff should ensure that the patients hands are cleaned with soap and water particularly after using the lavatory/commode and before meals. Soap and water in a bowl or disposable patient wipes should be offered at the bedside of immobile patients. b) Patients may be showered if their condition permits. 6.8 Equipment a) Where possible, patients should be allocated equipment that is single patient use/disposable/ or equipment that can remain with the patient during their period in isolation. b) Notes and charts should be kept outside the room (in a manner that ensures the patient privacy is protected). c) Non disposable equipment should be thoroughly cleaned after use or when no longer required using a 1,000ppm hypochlorite/detergent solution (Actichlor plus solution). This includes equipment such as hoists and physiotherapy equipment. d) Any equipment that is multi-patient use must be decontaminated in between patient use and in accordance with the manufacturer s instructions e) Equipment should be disposed of or decontaminated when the patient is removed from isolation or discharged. f) If a patient is not able to access ensuite facilities, they must have a commode dedicated for their use. g) Commodes must be cleaned after each use using an Actichlor plus solution. h) Fans should not be used as they can circulate infectious spores. i) All pillows should have heat sealed plastic covers. This cover should be intact with no evidence of wear and tear. Any worn or torn pillows should be disposed of as clinical waste. Pillows should be cleaned daily using Actichlor plus solution. 21

22 j) Mattresses should be checked daily for visible tears If the cover is torn inform the nurse in charge and dispose of mattress by contacting the portering staff and requesting the removal of the mattress for disposal as clinical waste immediately. Mattresses should be cleaned daily using an Actichlor plus solution k) The patient s bed linen should be changed at least daily. 6.9 Environment a) The patient s room and en suite toilet facility must be fully cleaned three times daily while the patient is symptomatic. b) All areas should be cleaned using a 1,000ppm hypochlorite/detergent solution (Actichlor plus solution). c) The room must be kept free from clutter at all times. d) When a patient no longer requires isolation or is discharged, a terminal clean of the room, en-suite facilities and equipment is required using Actichlor Plus solution (1,000 ppm hypochlorite/detergent) Waste a) All waste should be disposed of as clinical waste 6.11 Laundry a) All linen managed as infected linen b) Patient clothing should be placed into a patient property bag prior to sending it home with the carer. e) Relatives/carers should be given advice on the laundering of clothing and this followed up by giving the laundry advice leaflet. 22

23 6.12 Visitors a) Visitors should be advised to wash their hands with soap and water on entering and prior to leaving the isolation room. b) If a patient is experiencing profuse diarrhoeal symptoms, restrict visiting to close family members until symptoms subside. c) Visitors with only social contact DO NOT need to wear protective clothing. Visitors who assist the patient with personal care or who have extensive patient contact should wear gloves and aprons for these procedures Attendance at Other Departments a) Attendances to other departments should be kept to a minimum. When this is necessary, for investigation or treatment, prior arrangements should be made with the Senior Staff of that department (e.g. x ray, theatres) enabling contact infection prevention & control precautions to be maintained. The patient should be called for when the department is ready and they should spend a minimum time in the department. The equipment used to transfer the patient, e.g. a trolley; should be decontaminated after use using a 1,000ppm hypochlorite/detergent solution (Actichlor plus solution) Guidance on the Discharge or Transfer of Patients with CDI a) Patients with C. difficile diarrhoea should NOT be transferred to other wards in the hospital, except for purposes of isolation or enhanced medical care (e.g. ICU). I. Patients must meet the criteria for the appropriate facility as set out in the appropriate sections below. II. The facility the patient is to be transferred to needs to be fully informed of the patient s C. difficile status and if applicable, other infection control issues prior to transfer. 23

24 III. The Health Protection or Infection Control Nurse of the receiving facility must be informed of the proposed transfer to the facility Transfer to another ward within the hospital. Patients who have had a C. difficile infection may only be transferred to another ward within the hospital when: 1) It is a medical emergency Or 2) The patient is 72 hours asymptomatic of diarrhoea AND The patient has a minimum of 1 preferably 2 consecutive formed motions Transfer to a Residential/Nursing Home/Other Hospitals 1) Patients who had a C difficile infection may be transferred to a single room in a nursing/residential home/other hospital when assessed by the multidisciplinary team as medically fit for discharge/transfer AND The patient is 72 hours asymptomatic of diarrhoea AND The patient has a minimum of 1 but preferably 2 consecutive formed motions A completed notification of infection status patient transfer form must accompany the transfer letter The facility the patient is transferring to must be informed to contact the patient s GP should symptoms reoccur. If ward staff experience difficulty in transferring patients to these facilities please discuss with a member of IPCT Discharged to home 1) Patients may be discharged to their home when: The patient is considered to have mild or moderate disease AND The patient is clinically improving and medically fit for discharge AND The patient is able to complete their course of treatment for CDI at home if applicable. Discharging Physician to complete a C. difficile discharge form to accompany the customary discharge letter. 24

25 6.16 Ambulance Transfers a) Ambulance staff should maintain contact infection control precautions for the transfer of CDI patients End of Life Care a) The advice of the palliative care team should be sought for patients in whom a fatal outcome is a possibility 6.18 Death of a patient with CDI a) Infection control precautions for handling deceased patients are the same as those used when the patient is alive. b) Faecal soiling around the cadaver should be cleaned first with an Actichlor plus solution. c) Plastic body bags are not necessary d) Mortuary staff and undertakers should use standard infection control precautions including hand washing using soap and water. e) The patient s Consultant/Lead Nurse and infection control nurse must be informed of the death of a patient with CDI Documentation on the death of a patient with CDI a) Accurate documentation is required for recording the death of a patient with Clostridium Difficile infection (CDI) by the: Completion of the Checklist After the Death of a Patient Completion of the death certificate Completion of the stub in the death certificate book And If death is within 30 days of a Clostridium difficile toxin positive result - Completion of Datix 6.19 Death Certification and Checklist After the Death of a Patient 25

26 If a healthcare associated infection [HCAI] was part of the sequence leading to the death, or as the certifying doctor you think it may have contributed to the death, you should discuss this with a consultant or senior doctor prior to completing the death certificate. 1. It is a clinical judgement whether a condition the patient had - either at death or in the preceding period - contributed to their death. This decision will inform whether or not Clostridium difficile should be included on the Medical Certificate of the Cause of Death [MCCD] 2. Where appropriate, HCAI must then be noted in the relevant section of the Death Certificate If a HCAI was part of the direct sequence leading to death, it should be recorded in Part I of the death certificate. This should include all conditions in the sequence of events back to the original disease being treated. If the patient had a HCAI which was not part of the direct sequence, but you think it contributed to their death, it should be mentioned in Part II of the death certificate 3. The Checklist after the Death of a Patient should be completed by the clinical team at the time of death. - The white copy of the Checklist after the Death of a Patient should be filed in and forwarded to Clinical Coding. - The yellow copy should be placed in the patients notes 4. The Datix should be completed by the Ward Manager when a patient dies within 30 days of being diagnosed with Clostridium difficile Death of a patient within 30 days of Clostridium difficile diagnosis These cases will be reviewed by the Consultant responsible for the patient at the time Clostridium difficile was diagnosed. The outcome of this review will be presented at the Morbidity & Mortality meeting by the Consultant and issues arising from these cases will be forwarded by the Chair of the Morbidity & Mortality meeting to the Medical Director, for onward discussion as appropriate. 26

27 7.0 Environmental Cleaning and Decontamination of Equipment Environmental contamination occurs as a result of C. difficile spores being expelled into the environment when patients have diarrhoea with large amounts of liquid stools or faecal incontinence. Heavy contamination can be found on floors, toilets commodes and beds. The isolation room and en suite facilities must be cleaned at least three times daily using Actichlor Plus solution (1,000 ppm available chorine hypochlorite/detergent). See Trust guidance for Isolation cleaning Increased frequency is required if the patient is experiencing profuse diarrhoea Equipment such as mops and buckets used for cleaning should be the appropriate colour code (yellow) and dedicated to the room of the CDI patient. Special attention should be paid to frequently touched surfaces such as tables, chairs, door handles, call bells and all horizontal surfaces. All pillows should have heat sealed plastic covers. Mattress covers should be intact with no evidence of wear and tear. Any worn or torn pillows or mattresses should be disposed of as clinical waste Any concerns in relation to the standard of environmental cleanliness must be reported to domestic supervisor immediately to allow prompt rectification of the problem. When a patient is asymptomatic or discharged a terminal clean of the room, en-suite facilities and equipment including the commode is required using Actichlor Plus solution (1,000 ppm hypochlorite/detergent). See Trust guidance for terminal cleaning. Check Mattress for visible stains or tears Visually inspect all surfaces of the mattress for stains or tears. Unzip the mattress cover. Inspect the inner cover for stains or tears. Inspect the foam for stains. If the cover is stained or torn or the foam is stained inform the nurse in charge and dispose of mattress by contacting the portering staff and requesting the removal of the mattress for disposal as clinical waste immediately. If there are no visible stains or tears zip the mattress cover up fully. NOTE: Chlorine containing cleaning agents must be made up to correct concentration and stored in accordance with COSHH regulations. 27

28 APPLIED BRISTOL STOOL CHART Patient Name: Date of Birth: Hospital Number: Ward: Date sample sent: DAY DATE TIME AMOUNT (mls) TYPE / CONSISTENCY (see over for Applied Bristol Stool Scale) COLOUR BLOOD VISIBLE Specimen sent SIGNATURE To be completed after each bowel movement Note on a daily basis if a patient does not have a bowel movement. 28

29 Applied Bristol Stool Chart Guidance on assessment and collection of faecal samples for laboratory testing Type 1 Type 2 Type 3 Stools appear in separate hard lumps, similar to nuts. This is a strong sign the patient may be constipated. Stools are sausage-like in appearance but lumpy. This stool type may also indicate constipation. Stools come out similar to a sausage but with cracks in the surface. This is a normal stool. Do not send sample Do not send sample Do not send sample Type 4 Stools are smooth and soft in the form of a sausage or snake. This is a normal stool. Do not send sample Type 5 Type 6 Soft stools form soft blobs with clearcut edges, and are easily passed through the digestive system. This stool may be a normal stool for some patients known to have bowel disease such as Crohn s disease, IBS, Diverticulitis, etc but may also represent bowel disease. May take the shape of the container. Consult with medical staff Stools have fluffy pieces with ragged edges. Considered mushy stools, they indicate diarrhoea. Takes the shape of the container. If not normal bowel habitus send sample if unexplained diarrhoea Send sample if unexplained diarrhoea Type 7 Stool is of a watery, liquid consistency with no solid pieces. Is indicative of severe diarrhoea possibly as a result of bacterial or viral infection. Takes the shape of the container Send sample if unexplained diarrhoea All patients with 2 or more episodes of unexplained diarrhoea should have a sample of stools sent 29

30 C DIFFICILE INFECTION DAILY ASSESSMENT SHEET Medical staff are to complete this form on a daily basis from confirmation until symptoms have resolved completely When Clinician has informed patient of C difficile infection Please sign: Date: Time: ADDRESSOGRAPH LABEL Day Date Total number of bowel motions in last 24 hours Applied Bristol stool Chart. classification e.g. Type 4 White cell count 10⁹/L CRP mg/l U&E Fluid balance for the last 24 hours Maximum temperature in 24 hours Is the patient on the appropriate treatment for C difficile Was the patient given a laxative/enema within the last 24 hours Yes/No If yes give reason (in comments) Was the patient given acid suppressing medications within the last 24 hours Yes/No If yes give reason Was an abdominal examination performed today Yes/No If No give reason Initial of person completing assessment Additional Comments e.g. reason for laxatives, PPI 30

31 Clostridium difficile infection Care Bundle Patient s Name:.. Hospital Ward... Audit to be completed on a daily basis, on all new C diff positive patients, by the ward Manager/Nurse in Charge and filed in the patient s notes Section 4 Date Is the patient isolated appropriately in a single room Yes/No Ensuite toilet Yes/No Is the room clean and free of clutter (Actichlor plus used & enhanced cleaning in place) CHECK Yes/No Are all staff aware of the need to wash their hands. Alcohol hand rub is used following hand washing in augmented care areas CHECK Yes/No PPE is used appropriately Apron and gloves for patient /environment contact OBSERVE Yes/No Is the Applied Bristol Stool Chart In use and updated daily CHECK Daily Review is updated daily CHECK Yes/No Is the patient responding to treatment Yes/No If no has the antimicrobial treatment been reviewed Yes/No Comments Signature Yes/No 31

32 Clostridium difficile positive Patient Contact List To be completed by the ward manager if patient was symptomatic while in a multiple bedded area (2, 3, 4, 6 bedded bay) Clostridium difficile positive patient information Patient name Healthcare Number Date of GDH and Toxin positive result Ward Bay Number of patients in this bay List hospital numbers of the patients in this bay while the patient was symptomatic (retain this list in the C difficile positive patient s medical notes) Patient Name Patient Name Healthcare number Healthcare number Patient Name Patient Name Healthcare number Healthcare number Patient Name Patient Name Healthcare number Healthcare number 32

33 Disinfection of Required Concentration of chlorine Environment and Equipment 1,000 ppm available chlorine ActiCHLOR PlusTM DILUTION CHART Dilutions 1.7g tablets (Actichlor Plus) 1 tablet in 1 litre Additional Advice Prepare Actichlor Plus solution by adding 1 tablet to 1 litre of cold water in the Actichlor dilution bottle. Or use 5 tablets in a mop bucket with 5 litres of cold water. Use this solution to clean and disinfect the area. Discard solution after use. Rinse excess from Stainless Steel bed frames or trolleys with a damp cloth Discard unused solution after 24 hours from preparation Do s Always prepare in a well-ventilated area Use cold water Always use correct dilutions Replace lid after use Keep out of reach of children Always decontaminate hands after removing glove Don ts Do not use hot or boiling water Do not take internally Do not mix with acids or detergents Do not use on fabric Do not pour solution directly onto urine spills 33

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