MedStar Health Ambulatory Clinical Practice Guideline

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1 Title: Antimicrobial Stewardship Community Acquired Pneumonia MedStar Health Ambulatory Clinical Practice Guideline Clinical Policy: New X Revised Reviewed Purpose: Ambulatory Management of Patients in Community Setting Effective Date: 09/01/2015 Adult Scope: Community Acquired Pneumonia (CAP) remains one of the leading causes of death in the United States. According to one estimate, almost 1 million episodes of CAP occur in adults age 65 and older each year in the United States. There is considerable variability in rates of hospitalization, in part because there is several different severity rating tools available for determining which patients should be treated in the hospital or treated as outpatients. Physicians often overestimate severity and hospitalize a significant number of patients at low risk for death. These guidelines focus on identification and management of patients with CAP who are at low risk for death and other adverse outcomes and who can be treated in outpatient care settings. They are not intended either to replace a clinician s judgment or to establish a protocol for all patients with a particular condition. Previous guidelines have excluded patients with HIV; however the most recent Infectious Diseases Society of America and American Thoracic Society guidelines for CAP do not make this distinction. While HIV patients may be at higher risk for pneumococcal pneumonia, the treatment principles are generally the same. Points where evaluation and management differ for HIV-infected patients are noted in this document. I. Initial Presentation A. Patient may present with the following signs and symptoms below: Cough with or without sputum Cough with or without sputum Hemoptysis Gastrointestinal symptoms Pleuritic chest pain Myalgias Rales, rhonchi, wheezing Dyspnea Malaise, fatigue Temperature > 38 o C (100.4 o F) Egophony, bronchial breath sounds, dullness to percussion Atypical symptoms in older patients (confusion, delirium) B. Chest X-ray is necessary to confirm the diagnosis. In older patients and individuals with co-existing illness the x-ray can help exclude other diseases that can mimic pneumonia i.e. CHF, bronchial obstruction, or suggest other specific diagnoses i.e. lung tumors or pleural effusions or assess severity of illness by locating infiltrates in more than one lobe. A negative chest X-ray does not completely rule out pneumonia. Routine follow up chest x- ray is not recommended on every patient. However, followup chest x-rays are indicated in selected patients, i.e. > 40 years of age and/or smokers. The recommended time interval for follow up chest x-ray is between 7-12 weeks.

2 II. Risk factors associated with a possible complicated course of CAP A. Coexisting illness/conditions: Age >60 years Use of antibiotics within past 3 months Malnutrition COPD Suspicion of aspiration Immunosuppression/HIV Diabetes Mellitus Altered mental status Asplenia Chronic renal failure, liver disease and/or heart disease Hospitalization within the past year for CAP Malignancies B. Indicators of severe CAP on presentation: Respiratory rate 30/min or greater Temperature < 36 o C (96.8 o F) Diastolic blood pressure < 60 mmhg Confusion/disorientation Systolic blood pressure < 90 mmhg C. Chest x-ray findings: Multilobar infiltrates Cavitation Pleural effusions Necrosis III. Severity of Illness Scoring and Prognostic Models Every patient should be assessed for admission versus outpatient treatment using a severity scale. The two most commonly used are the Pneumonia Severity Index (PSI) and the CURB-65. The PSI has been more widely studied and validated but is more cumbersome than the CURB-65. A. Pneumonia Severity Index (PSI) This is a prediction model that assigns points based on age, coexisting disease and initial presentation. The PSI risk class, which correlates directly with mortality rate, ranges from I to V. Risk class I has the lowest mortality rate while risk class V has the highest mortality rate. The PSI risk class determination is a two step process. The first step is to determine if the patient is in risk category I. This is based solely on the history and physical examination. If the patient is <50 years of age, has no history of comorbidity and the physical exam reveals normal mental status, pulse <125, RR<30, SBP>90 and temperature >35 C but 40 C, then the patient is risk category I and no further workup is required. If the patient is Page 2 of 9 Outpatient Management of Patients with Community Acquired Pneumonia

3 not a risk category I, the next step utilizes blood tests (chemistry and ABG) and a CXR. These results determine which risk category (II-V) the patient is placed. Utilizing the mortality rates, risk class I and II can generally be treated as outpatients, risk class III can be treated with a short hospitalization, and risk class IV and V require hospitalization. Note that the PSI scoring system has not been formally validated for HIV-infected patients and does not include specific variables related to HIV infection (such as CD4 count). Studies that have utilized the PSI score in HIV patients have shown its utility, particularly in patients with high CD4 counts. However, up to 20% of HIV- infected patients have bacteremic disease despite low PSI scores. PSI Scoring System Demographic Factor Score Age: Men Age in years Women Age 10 Nursing Home Resident Age + 10 Coexisting Illnesses Neoplastic disease +30 Liver Disease +20 Congestive heart failure +10 Cerebrovascular Disease +10 Renal Disease +10 Physical Examination Findings Altered Mental Status +20 Respiratory Rate > Systolic Blood Pressure <90 mmhg +20 Temperature < 35 or > 40 C +15 Pulse > 125/min +10 Laboratory and Radiographic Findings Arterial ph < BUN > 30 mg/dl +20 Sodium <130 meq/l +20 Glucose >250 mg/dl +10 Hematocrit < 30% +10 Partial pressure of arterial oxygen < 60mmHg +10 or Pleural O2 sat<90% effusion +10 TOTAL SCORE Treatment setting decision based on PSI score Patient Score Class Treatment Setting Age < 50y, no coexisting illness, negative Class I Outpatient physical exam findings Class II Outpatient Class III Overnight admission Class IV Hospital Unit Page 3 of 9 Outpatient Management of Patients with Community Acquired Pneumonia

4 >130 Class V ICU Fine MJ et al. Prediction Rule to Identify Low-Risk Patients with Community-Acquired Pneumonia. N Engl. J. Med., 1997; 336 (4): ) Page 4 of 9 Outpatient Management of Patients with Community Acquired Pneumonia

5 B. CURB-65 Score One point is assigned for the presence of each of the following: Confusion Uremia (BUN greater than 20 mg/dl) Respiratory rate 30 breaths/minute Blood pressure (systolic < 90 or diastolic 60 mmhg) Age greater than or equal to 65 Treatment setting decision based on CURB-65 score CURB-65 Score Treatment Setting 0-1 Outpatient 2 Inpatient 3-5 Inpatient-ICU C. Note that scoring systems are not intended to replace clinical judgment. Certain patients with low PSI or CURB-65 scores may require hospitalization, whereas other patients with high PSI scores due to advanced age and multiple stable chronic illnesses may be managed successfully as outpatients in some instances. Other considerations not taken into account by this guideline may influence a clinician s decision to admit a patient. D. HIV-infected patients, particularly those with advanced disease (CD4 count less than 200 cells/mm 3 ) typically require blood cultures to rule out bacteremia as well as sputum and urinary antigen testing. This may give reason to admit a patient if these tests cannot be performed as an outpatient. IV. Primary Pathogens A. Common etiologies of outpatient CAP include: Streptococcus pneumoniae, Mycoplasma pneumoniae, Haemophilus influenza, Chlamydophila (formerly Chlamydia) pneumoniae, and respiratory viruses (Influenza A and B, adenovirus, respiratory syncytial virus, and parainfluenza). B. Atypical organisms, so called because they are not detectable on Gram stain or culturable on standard bacteriologic media, include Mycoplasma pneumoniae, Chlamydophila pneumoniae, Legionella pneumophila, and respiratory viruses. With the exception of Legionella, these are common causes of CAP. C. Epidemiologic conditions and risk factors related to specific pathogens in community acquired pneumonia are listed in the table below. Note that empiric therapy for CAP does not necessarily cover all of these organisms and further work-up may be necessary. Page 5 of 9 Outpatient Management of Patients with Community Acquired Pneumonia

6 CAP pathogens associated with certain conditions Condition Commonly encountered pathogens Alcoholism Streptococcus pneumoniae, oral anaerobes, Klebsiella pneumoniae, Acinetobacter species, Mycobacterium COPD and/or smoking Haemophilus influenzae, Pseudomonas aeruginosa, Legionella species, S. pneumoniae, Moraxella cararrhalis, Chlamydophila pneumoniae Aspiration* Gram-negative enteric pathogens, oral anaerobes Lung abscess CA-MRSA, oral anaerobes, endemic fungal pneumonia, M. tuberculosis, atypical mycobacteria Exposure to bat or bird droppings Histoplasma capsulatum Exposure to birds Chlamydophila psittaci (if poultry: avian influenza) Exposure to rabbits Francisella tularensis Exposure to farm animals or parturient cats Coxiella burnetti (Q fever) HIV infection (early) S. pneumoniae, H. influenzae, M. tuberculosis HIV infection (late) S. pneumoniae, H. influenzae, M. tuberculosis, Pneumocystis jirovecii, Cryptococcus, Histoplasma, Aspergillus, atypical mycobacteria (especially Mycobacterium kansasii), P. aeruginosa Hotel or cruise ship stay in previous 2 weeks Legionella species Travel to or residence in southwestern United Coccidioides species, Hantavirus States Travel to or residence in Southeast and East Asia Burkholderia pseudomallei, avian influenza, SARS Influenza active in community Influenza, S. pneumoniae, Staphylococcus aureus, H. influenzae Cough 12 weeks with whoop or posttussive Bordetella pertussis vomiting Structural lung disease (e.g., bronchiectasis) Pseudomonas aeruginosa, Burkholderia cepacia, S. aureus Injection drug use S. aureus, anaerobes, M. tuberculosis, S. pneumoniae Endobronchial obstruction Anaerobes, S. pneumoniae, H. influenzae, S. aureus In context of bioterrorism Bacillus anthracis (anthrax), Yersinia pestis (plague), Francisella tularensis (tularemia) *Anaerobic coverage is clearly indicated only in the classic aspiration pleuropulmonary syndrome in patients with a history of loss of consciousness as a result of alcohol/drug overdose or after seizures in patients with concomitant gingival disease or esophogeal motility disorders D. Drug-resistant S. pneumoniae (DRSP) 1. Risk factors for infection with b-lactam resistant S. pneumoniae include age less than 2 years or greater than 65 years, beta-lactam therapy within the previous 3 months, alcoholism, multiple comorbidities, Page 6 of 9 Outpatient Management of Patients with Community Acquired Pneumonia

7 immunosuppressive illness or therapy, and exposure to a child in a day care center. 2. Recent treatment with antimicrobials is likely the most significant risk factor. Recent therapy or repeated courses of therapy with beta-lactams, macrolides, or fluoroquinolones are risk factors for pneumococcal resistance to the same class of antibiotic. V. Management Course A. Chest X-ray (CXR) should be performed to confirm diagnosis of CAP. 1. See CXR findings section II.C. above 2. Rule-out Pneumocystis jiroveci pneumonia (formerly known as Pneumocystis carinii pneumonia (PCP)) in HIV patients (CD4 count less than or equal to 250 cells/mm 3 ) with absence of infiltrate on CXR, non-productive cough, and high clinical suspicion of pneumonia. B. Patients should be screened by pulse oximetry to rule out unsuspected hypoxemia. C. Routine diagnostic tests to identify an etiologic diagnosis (i.e. sputum culture) are optional for outpatients with CAP as most patients respond well to empiric therapy. D. Clinical indications for more extensive diagnostic testing are listed below. Clinical indications for additional diagnostic testing for CAP Indication Failure of outpatient antibiotic therapy Blood Culture Sputum Culture Legionella Urinary Antigen Test Pneumococcal Urinary Antigen Test Other Cavitary infiltrates Fungal & Tuberculosis cultures Leukopenia Active alcohol abuse Severe chronic liver disease Asplenia (functional or anatomic) Recent travel (within past 2 weeks) X X Common respiratory Pleural effusion X pathogens in area of travel Thoracentesis and pleural fluid cultures Page 7 of 9 Outpatient Management of Patients with Community Acquired Pneumonia

8 Severe structural lung disease X Common respiratory pathogens in area of travel Page 8 of 9 Outpatient Management of Patients with Community Acquired Pneumonia

9 E. HIV patients experience a high proportion (up to 20%) of bacteremic forms of pneumococcal pneumonia, therefore urine pneumococcal antigen test should be performed in all HIV patients with CAP (this is consistent with recommendations for leukopenic patients in above table). F. Rule out pulmonary tuberculosis (TB) in HIV patients (any CD4 count) presenting with a cough > 2 wks, fever, night sweats, weight loss, hemoptysis, shortness of breath, chest pain; consult infectious disease physician G. Blood cultures are indicated for patients with severe CAP. VI. Drug Therapy: A. Recommended antibiotics in previously healthy outpatients (including HIV patients with CD4 count greater than 200cells/mm3) with no risk factors for drug-resistant S. pneumoniae: Outpatient empiric drug therapy for uncomplicated CAP Class Agent Dosing Macrolide (Preferred)** azithromycin, or 500 mg PO once daily x 1day, then 250mg once daily x 4 days ($110) clarithromycin, or erythromycin* 500 mg PO twice daily x 7 days ($63) OR 1 g (extended-release) PO daily x 7 days ($140) 500 mg PO every 8 hours x 7-10 days ($220-$315) Tetracycline doxycycline 100 mg PO twice daily x 7-10 days ($38 or higher based on supply) *Erythromycin : Not commonly used due to GI intolerance and lack of activity against H. influenza; should not be used if H. influenza suspected (i.e. in patients with comorbidities such as COPD). **Macrolides can cause QT prolongation. Risk factors include advanced age, hypokalemia, hypomagnesemia, clinically significant bradycardia, and the use of other agents that prolong the QT interval. B. Recommended antibiotics for patients with the presence of comorbidities such as chronic heart, lung, liver, or renal disease; diabetes mellitus; alcoholism; malignancies; asplenia; immunosuppressing conditions** (including HIV with CD4 count less than or equal to 200 cells/mm 3 ) or use of immunosuppressant drugs;** use of antimicrobials within the previous 3 months ; or other risks for DRSP infection. Page 9 of 9 Outpatient Management of Patients with Community Acquired Pneumonia

10 Drug therapy for CAP patients with comorbidities or risk factors for DRSP Class Agent Dosing Moxifloxacin (Avelox ) Respiratory fluoroquinolone Levofloxacin (Levaquin ) 400 mg PO once daily x 7 days ($190) 750 mg PO once daily x 5 days ($180) Beta-lactam plus macrolide Gemifloxacin (Factive ) Preferred: Amoxicillin (high dose), or Amoxicillin-clavulanate (high dose) (Augmentin XR ), or Alternatives: Cefpodoxime (Vantin ), or Cefuroxime (Ceftin ) PLUS Azithromycin, or Clarithromycin 320 mg PO once daily x 7 days ($298) 1 g PO three times daily x 7-10 days ($16-$23) 1000/62.5mg: 2 tabs PO twice daily x 7-10 days ($54-$77) 200 mg PO twice daily x 14 days ± ($118) 500 mg PO twice daily x 7-10 days ± ($112-$160) 500 mg PO once daily x1day, then 250mg once daily x 4 days ($110) 500 mg PO twice daily x 7 days ($63) OR 1 g (extended-release) PO daily x 7 days ($140) Use agent from a different class than previous antibiotic ** Rule out PCP in immunosuppressed patients, consult infectious disease physician ± Shorter course of 5-10 days acceptable if patient afebrile for 48 hours on treatment Doxycycline may be used as alternative to macrolide; dosing and duration as in previous table Fluoroquinolone Warnings/ Precautions: Fluoroquinolone use may cause peripheral neuropathy or QT prolongation. Risk factors include advanced age, hypokalemia, hypomagnesemia, clinically significant bradycardia, and the use of other agents that prolong the QT interval. Tendon inflammation and/or rupture have also been reported. Risk may be increased with concurrent corticosteroids, organ transplant recipients, and in patients >60 years if age. In patients with myasthenia gravis, use may exacerbate muscle weakness. Patients should promptly report any symptoms. The drug should be discontinued. VII. Duration of treatment: A. Most patients with CAP have traditionally been treated for 7-10 days or longer. However, there are very few well-controlled studies that have evaluated the optimal duration of therapy. Page 10 of 9 Outpatient Management of Patients with Community Acquired Pneumonia

11 B. Patients should be treated for a minimum of 5 days, should be afebrile for 48 hours, and have no more than 1 CAP-associated sign of clinical instability before discontinuation of therapy. VIII. Patient Education: Patient information can be obtained through the Clinical Reference System: Adult Health Advisor, Pneumonia or via Medline Health topics a Please review below information with your patients. 1. Bacterial pneumonia is treated with antibiotics. 2. Most cases of pneumonia can be treated without hospitalization. 3. The need for hospitalization depends on: The extent of the illness Whether you live alone and how well you can take care of yourself How old you are Whether you live in a nursing home and what health care is available there Whether pneumonia is a complication of another disease. 4. Pneumonia isn't usually contagious and can normally be cured in 1 or 2 weeks with treatment. Recovery may take longer for young children, adults over age 60, and people with other illnesses. Your body helps to fight the infection in addition to antibiotics. 5. Patients should follow these self-care treatment guidelines: Rest in bed until fever disappears and pain and shortness of breath decrease Increase the amount of water, tea, or fruit juice you drink to about 2 to 3 quarts each day. The extra fluid will help you cough up lung secretions more easily. Cough up lung secretions as much as possible Use a cool-mist humidifier to increase moisture in the air Use cough medicine only if your cough is dry and the doctor agrees Use a heating pad on a low setting to reduce chest pain Use over-the-counter drugs such as acetaminophen (Tylenol ) to relieve minor discomfort 6. Offer Influenza (October-March) and Pneumococcal vaccinations to at-risk patients. Encourage patients meeting criteria to obtain annual influenza vaccination. 7. Call physician if: Symptoms do not improve in 72 hours Coughing up blood Become mentally confused Chest pain is not relieved by heat or prescribed medication Beginning to be nauseous, vomit, or have diarrhea Skin, fingernails, or toenails turning blue Temperature > than 102 F (39 C) Shortness of breath increases Any new symptoms appear Page 11 of 9 Outpatient Management of Patients with Community Acquired Pneumonia

12 Page 12 of 21 VII. References 1. Madnell LA, Winderink RG, Anzueto A, et al. Infectious Diseases Society of America/American Thoracic Society Consensus Guidelines on the Management of Community-Acquired Pneumonia in Adults. Clin Infect Dis. 2007;44(suppl 2):S Madeddu G, Fois AG, Pirina P, Mura MS. Pneumococcal pneumonia: clinical features, diagnosis, and management in HIV-infected and HIV-noninfected patients. Curr Opin Pulm Med. 2009;15: Bartlett JB. Pneumonia, Community-Acquired. Hopkins-Abx Guide. Updated 1/ Nuermberger, E. Pneumonia, bacterial. Johns Hopkins HIV Guide. Updated Bartlett JB. Pneumonia, Acute [HIV]. Hopkins-Abx Guide. Updated 1/15 6. File TM. Treatment of community-acquired pneumonia in patients in the outpatient setting, UpToDate (Wolters Kluwer). Updated 4/6/ The Sanford Guide to Antimicrobial Therapy 2014; 44 th Edition Outpatient Management of Patients with Community Acquired Pneumonia Guideline initiated Clinical Guidelines are reviewed every two years by a committee of experts in the field. Updates to guidelines occur more frequently as needed when new scientific evidence or national standards are published. September 2017 Pediatric Ambulatory Workgroup &

13 Page 13 of 21 Pediatric Scope: Pneumonia and influenza were the 6 th leading cause of death in children 1-4 years of age, 7 th leading cause of death in children 5-9 years of age and 8 th leading cause of death in children years of age in the United States in (Center for Disease Control, 2013) Worldwide, pneumonia is the leading infectious cause of death in children, accounting for 15% of all deaths in children less than 5 years of age. (World Health Organization, 2014) Several key factors that are known to increase the severity of illness include malnutrition, prematurity, low socioeconomic status, exposure to tobacco smoke and daycare attendance. (Stuckey-Schrock, Hayes, & George, Community-Acquired Pneumonia in Children, 2012) These guidelines are intended to assist clinicians in treating community acquired pneumonia in otherwise healthy infants and children older than 3 months of age. These guidelines do not pertain to infants 3 months of age, immunocompromised children, children with chronic lung disease (ex: cystic fibrosis) or ventilator dependent children. I. INITIAL PRESENTATION Fever (temperature 38.0 C or F) Cough Abnormal lung sounds (rhonchi, crackles, wheezing, rales) Variable degrees of respiratory distress (tachypnea, dyspnea, retractions, grunting, nasal flaring, apnea, altered mental status) II. RISK FACTORS A. General Risk Factors Age < 5 years Male Prematurity (Harris M., et al., 2011) Malnutrition Exposure to tobacco smoke Childcare attendance Low socioeconomic status (Stuckey-Schrock, Hayes, & George, Community-Acquired Pneumonia in Children, 2012) B. Risk Factors for Progressive Disease in Hospitalized Children (Huang, et al., 2013) Age <2 Pleural effusion Tachypnea Hemoglobin < 10 White blood cell count > 17,500/ μl Persistent fever > 3 days III. SELECTION OF CARE SETTING (Bradley J., et al., 2011) September 2017 Pediatric Ambulatory Workgroup &

14 September 2017 Pediatric Ambulatory Workgroup & Page 14 of 21 A. Conditions that favor Outpatient management: Absence of respiratory distress (no tachypnea, dyspnea, retractions, grunting, nasal flaring, apnea, altered mental status) Sustained SpO2 90% Adequate outpatient caregiver support/ability to be compliant with outpatient therapy B. Conditions that favor Inpatient management: Respiratory distress (tachypnea, dyspnea, retractions, grunting, nasal flaring, apnea, altered mental status) Sustained SpO2 < 90% 3-6 months of age with suspected bacterial pneumonia Suspected pathogen with increased virulence (ex: MRSA) Poor outpatient support/concerns about the ability to be compliant with outpatient therapy C. Conditions that favor ICU management: Mechanical ventilation, CPAP, BiPAP Impending respiratory failure Unstable hemodynamics (sustained tachycardia, hypotension, requiring vasopressors) SpO2 < 92% on inspired oxygen 0.50 Altered mental status IV. PATHOGENESIS: In many children, testing may indicate 2 or 3 pathogens, including combinations of viruses and bacteria. A 2011 study of 76 hospitalized children with CAP found 18 distinct viruses and six bacteria in sputum samples by culture and PCR. Viruses were found in 72% of samples. Bacteria were found in 91% of samples. Both viruses and bacteria were found in 66% of samples. The most commonly found viruses were Rhinovirus (30%), human bocavirus (18%) and human metapneumovirus (14%). The most commonly found bacteria were Streptococcus pneumonia (50%), Haemophilus influenza (38%) and Moraxella catarrhalis (28%). The pairing of Rhinovirus and Streptococcus pneumoniae was the most common bacterialviral combination occurring in approximately 16% of cases. The clinical significance of the viral-bacterial combinations is not yet well understood, but the authors of this particular study found a potential association to treatment failure. (Honkinen, Lahti, Osterback, Ruuskanen, & Waris, 2012) Additionally, the incidences of certain pathogens vary by age group given the development of the immune system and age-related exposures. (Bradley J., et al., 2011) Specific Pathogens (McIntosh, Community-Acquired Pneumonia in Children, 2002) (Esposito, et al., 2012) (Honkinen, Lahti, Osterback, Ruuskanen, & Waris, 2012) A. Viruses Approximately 80% of CAP in children < 2 years of age is caused by a virus. The incidence of a viral etiology decreases with age. Viruses are responsible for CAP in children > 5 years of age in only 1/3 of cases. Common viruses:

15 Respiratory syncytial virus (found in up to 40% of children <2 years of age) Influenza A, B Parainfluenza viruses 1, 2 and 3 Rhinovirus Human metapneumovirus Human bocavirus Coronovirus Adenovirus Page 15 of 21 B. Atypical bacteria Mycoplasma pneumoniae Typically found in older children. Course is classically slowly progressive and is associated with malaise, low grade fever, sore throat and cough developing over 3-5 days. Chlamydophila trachomatis and Chlamydophila pneumonia More often found in infants than older children. C. Bacteria Streptococcus pneumonia (most common) Haemophilus influenzae type b Moraxella catarrhalis Staphylococcus aureus, including MRSA Nontypable Haemophilus influenza V. DIAGNOSTIC TESTING ROUTINELY RECOMMEDED Pulse oximetry should be performed in all children with pneumonia and suspected hypoxemia. The presence of hypoxemia should guide decisions regarding site of care and further diagnostic testing. Testing for influenza is recommended (when seasonally appropriate) as a positive test would guide appropriate antiviral therapy. Additionally, antibacterial therapy is not recommended for children with a positive influenza test unless there is compelling evidence that there is a bacterial coinfection. (Bradley J., et al., 2011) Mycoplasma testing should be performed for children with signs and symptoms consistent with but not classic for Mycoplasma pneumoniae to help guide antibiotic selection. NOT ROUTINELY RECOMMENDED Chest x-ray is not necessary to confirm CAP in patients well enough to be treated in the outpatient setting. Chest x-ray is recommended for all hospitalized patients in order to fully characterize the infiltrate and identify any possible complications that may warrant interventions beyond antimicrobial and supportive therapies. (Bradley J., et al., 2011) September 2017 Pediatric Ambulatory Workgroup &

16 Page 16 of 21 Blood cultures are not routinely recommended for non-toxic, fully immunized children being managed in the outpatient setting. Blood cultures should be obtained for children failing to demonstrate clinical improvement with initial antibiotic therapy as well as for children ill enough to require hospitalization. (Bradley J., et al., 2011) Acute phase reactants (ESR, CRP, procalcitonin) should not routinely be obtained in children managed as outpatients. They may be helpful in measuring the response to therapy in an inpatient setting. Chlamydophila pneumonia testing is not recommended as reliable and readily available diagnostic tests do not currently exist. Complete blood cell count is not recommended. However, it may provide useful information in those with more serious disease for clinical management in the context of clinical exam and other laboratory and imaging studies. Antibacterial therapy is not necessary for children with a positive test for influenza virus in the absence of clinical, laboratory, or radiographic findings that suggest bacterial coinfection. VI. DRUG THERAPY Amoxicillin should be used as first-line therapy for previously healthy, appropriately immunized infants and preschool children with mild to moderate CAP suspected to be of bacterial origin. Amoxicillin provides appropriate coverage for Streptococcus pneumoniae, the most prominent invasive bacterial pathogen. Table 1 lists preferred agents and alternative agents for children allergic to amoxicillin. Macrolide antibiotics should be prescribed for treatment of children (primarily school-aged children and adolescents) evaluated in an outpatient setting with findings compatible with CAP caused by atypical pathogens. Laboratory testing for M. pneumoniae should be performed if available in a clinically relevant time frame. Table 1 lists preferred and alternative agents for atypical pathogens. Influenza antiviral therapy (Table 2) should be administered as soon as possible to children with moderate to severe CAP consistent with influenza virus infection during widespread local circulation of influenza viruses, particularly for those with clinically worsening disease documented at the time of an outpatient visit. Because early antiviral treatment has been shown to provide maximal benefit, treatment should not be delayed for confirmation of positive influenza test results. Negative influenza diagnostic tests, especially rapid antigen tests, do not conclusively exclude influenza disease. Treatment after 48 hours of symptomatic infection may still provide clinical benefit to those with more severe disease. Table 1. Empiric Therapy for Outpatient Pediatric Community-Acquired Pneumonia (CAP) Outpatient Amoxicillin, oral 90 mg/kg/day Azithromycin oral (10 mg/kg (max. 500mg) Oseltamivir 24 months old: September 2017 Pediatric Ambulatory Workgroup &

17 Page 17 of 21 <5 years old (preschool) in 2 doses for 5 days ($5-$7 per bottle) Alternative: oral amoxicillin clavulanate amoxicillin component, 90 mg/kg/day in 2 doses for 5 days ($36 + per bottle) 5 years old Oral amoxicillin (90 mg/kg/day in 2 doses b to a maximum of 4 g/day ($5-$7 per bottle); for children with presumed bacterial CAP with inability to distinguish typical from atypical CAP, a macrolide can be added to a b-lactam antibiotic for empiric therapy; on day 1, followed by 5 mg/kg/day (max. 250 mg) once daily on days 2 5 ($35 per bottle ) Alternatives: oral clarithromycin (15 mg/kg/day in 2 doses for 7-14 days) ($53 per bottle) or oral erythromycin (40 mg/kg/day in 4 doses for 7-14 days) ($400 per bottle) Same as above ~4 mg/kg/day in 2 doses, for a 5-day treatment ($158 per bottle) 15 kg: 60 mg/day; >15 to 23 kg: 90 mg/day; >23 to 40 kg: 120 mg/day; >40 kg: 150 mg/day (divided into 2 doses for each group) 9 23 months old: 7 mg/kg/day in 2 doses; 0 8 months old: 6 mg/kg/day in 2 doses; premature infants: 2 mg/kg/day in 2 doses Same as above alternative: oral amoxicillin clavulanate (amoxicillin September 2017 Pediatric Ambulatory Workgroup &

18 Page 18 of 21 component, 90 mg/kg/day in 2 doses to a maximum dose of 4000 mg/day, eg two 1000 mg tabs twice daily (with max dose of 4000 mg/day ER $400 / 5 day course) For children with drug allergy to recommended therapy, see Evidence Summary for Section V. Anti-Infective Therapy. For children with a history of possible, nonserious allergic reactions to amoxicillin, treatment is not well defined and should be individualized. Options include a trial of amoxicillin under medical observation; a trial of an oral cephalosporin that has substantial activity against S. pneumoniae, such as cefpodoxime, cefprozil, or cefuroxime, provided under medical supervision; treatment with levofloxacin; treatment with linezolid; treatment with clindamycin (if susceptible); or treatment with amacrolide (if susceptible). For children with bacteremic pneumococcal pneumonia, particular caution should be exercised in selecting alternatives to amoxicillin, given the potential for secondary sites of infection, including meningitis. Abbreviation: CA-MRSA, community-associated methicillin-resistant Staphylococcus aureus. VII. VIII. IX. a See Table 1 for dosages. b See text for discussion of dosage recommendations based on local susceptibility data. Twice daily dosing of amoxicillin or amoxicillin clavulanate may be effective for pneumococci that are susceptible to penicillin. c Not evaluated prospectively for safety. DURATION OF TREATMENT A. Treatment courses of 10 days have been best studied, although shorter courses may be just as effective, particularly for more mild disease managed on an outpatient basis. B. Infections caused by certain pathogens, notably CA-MRSA, may require longer treatment than those caused by S. pneumoniae. C. The duration of antimicrobial therapy in children in the developed world has primarily been studied in the context of antibiotic registration trials, comparing newer agents with those having a standard treatment course of 10 days (5 days for azithromycin, which has distinctly different tissue-site pharmacokinetics compared with β-lactam antibiotics) in these protocols. (Bradley J. S., et al., 2011) MINMIZING ANTIMICROBIAL RESISTANCE 1. Antibiotic exposure selects for antibiotic resistance; therefore, limiting exposure to any antibiotic, whenever possible, is preferred. 2. Limiting the spectrum of activity of antimicrobials to that specifically required to treat the identified pathogen is preferred. 3. Using the proper dosage of antimicrobial to be able to achieve a minimal effective concentration at the site of infection is important to decrease the development of resistance. 4. Treatment for the shortest effective duration will minimize exposure of both pathogens and normal microbiota to antimicrobials, and minimize the selection for resistance. HOW SHOULD THE CLINICIAN FOLLOW THE CHILD WITH CAP FOR THE EXPECTED RESPONSE TO THERAYPY September 2017 Pediatric Ambulatory Workgroup &

19 Page 19 of 21 A. Children receiving adequate therapy should demonstrate clinical and laboratory signs of improvement within hours. For children whose condition deteriorates after admission and initiation of antimicrobial therapy or who show no improvement within hours, further investigation should be performed. X. PATIENT EDUCATION Please review the information below with your patients. A. Pneumonia is an infection of the lungs that can often be prevented with vaccines and can usually be treated with antibiotics, antiviral drugs (such as Tamiflu), or specific drug therapies. B. Pneumonia and other respiratory infections can be prevented by following good hygiene practices, such as washing your hands regularly and disinfecting frequently touched surfaces. C. Avoid exposure to cigarette smoke. D. Make sure the child is up to date on the vaccines that are recommended to prevent infection by bacteria or viruses that may cause pneumonia. These vaccines include: o Pneumococcal o Haemophilus influenza b (Hib) o Pertussis (whooping cough) o Varicella (chicken pox) o Measles o Influenza (flu) E. To protect infants from exposure, parents and caretakers of infants <6 months of age, including pregnant adolescents are recommended to get immunized with vaccines for influenza virus and pertussis. F. High-risk infants should be provided immune prophylaxis with respiratory syncytial virus (RSV)- specific monoclonal antibody to decrease the risk of severe pneumonia and hospitalization caused by RSV. G. Call your physician if your child shows any of the following warning signs that the pneumonia is worsening or spreading. Fever lasting more than a few days despite using antibiotics Breathing difficulties Evidence of an infection elsewhere in the body: red swollen joints, bone pain, neck stiffness, vomiting, or other new signs or symptoms. Skin, fingernails or toenails turn blue. H. Parents should follow these home care guidelines Rest. Increase fluid intake. Cough suppressants containing codeine or dextromethorphan should not be used, because coughing is necessary to clear the excessive secretions caused by the infection. September 2017 Pediatric Ambulatory Workgroup &

20 Page 20 of 21 Use over the counter drugs such as acetaminophen or ibuprofen to relieve fever or minor discomfort. References Bradley, J. S., Byington, C. L., Shah, S. S., Alverson, B., Carter, E. R., Harrison, C., et al. (2011). The Management of Community-Acquired Pneumonia in Infants and Children Older than 3 Months of Age: Clinical Practice Guidelines by the Pediatric Infectious Deseases Society and the Infectious Diseases Society of America. Clinical Infectious Diseases, 52. Center for Disease Control. (2013). 10 Leading Causes of Death by Age Group, United States Retrieved July 8, 2015, from cdc.gov: Esposito, S., Cohen, R., Domingo, J., Pecurariu, O., Greenberg, D., Heininger, U., et al. (2012). Do We Know When, What and for How Long to Treat?: Antibiotic Therapy for Pediatric Community-Acquired Pneumonia. The Pediatric Infectious Disease Journal, e78-e85. Harris, M., Clark, J., Coote, N., Fletcher, P., Harnden, A., McKean, M., et al. (2011). British Thoracic Society Guidelines for the Management of Community Acquired Pneumonia in Children: Update Thorax, ii1-ii23. Honkinen, M., Lahti, E., Osterback, R., Ruuskanen, O., & Waris, M. (2012). Viruses and Bacteria in Sputum Samples of Children with Community- Acquired Pneumonia. Clinical Microbiology and Infection, Huang, C.-Y., Chang, L., Liu, C.-C., Huang, Y.-C., Chang, L.-Y., Huang, Y.-C., et al. (2013). Risk Factors for Progressive Community-Acquired Pneumonia in Hospitalized Children: A Prospective Study. Journal of Microbiology, Immunology and Infection, McIntosh, K. (2002). Community-Acquired Pneumonia in Children. New England Journal of Medicine, Stuckey-Schrock, K., Hayes, B. L., & George, C. M. (2012). Community-Acquired Pneumonia in Children. American Family Physician, World Health Organization. (2014, November). World Health Organization. Retrieved July 8, 2015, from Fact Sheet: Pneumonia: Wubbel, L., Muniz, L., Ahmed, A., Trujillo, M., Carubelli, C., McCoig, C., et al. (1999). Etiology and treatment of community-acquired pneumonia in ambulatory children. The Pediatric Infectious Disease Journal, Outpatient Management of Pediatric Patients Three (3) Months and Older With Community Acquired Pneumonia Guideline initiated Clinical Guidelines are reviewed every two years by a committee of experts in the field. Updates to guidelines occur more frequently as needed when new scientific evidence or national standards are published. September 2017 Pediatric Ambulatory Workgroup &

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