Infection Data: Form Updates

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1 Infection Data: Form Updates Marcie Riches, MD, MS Associate Professor University of North Carolina Scientific Director, Infection and Immune Reconstitution WC

2 Overview Why is infection data important? Why is it so complicated? What to report

3 Infections account for 7 17% of the primary cause of death as reported to the CIBMTR The incidence of infection in transplant patients is much higher, with nearly 70% or more patients having at least one infection in the post-transplant period

4 Can infections be prevented? Guidelines published in 2009 for infection prevention 1 Prophylaxis and new antimicrobials have decreased early serious infections 2 CMV disease decreased by 48% GN bacteremia decreased by 39% Invasive mold infections decreased by 51% Invasive Candida infections decreased by 88% Later infections continue to remain a problem 1 Tomblyn et al, BBMT and BMT, Gooley et al, NEJM 2010

5 Prior Infection Prophylaxis Data Collected y/n for all drugs received after the start of the conditioning regimen * Results in data documenting patients receiving multiple drugs of the same class with no information on sequence/overlap*

6 Revised Infection Prophylaxis Data Collect medication prophylaxis data by antimicrobial type (i.e. bacterial, viral, fungal) Key change: Collect only the first drug started closest to the start of the preparative regimen Only in the antibacterial group can more than one drug be selected Both drugs must start at the same time!

7 2100 v 4.0 q Antibacterial Medications

8 2100 v 4.0 q Antiviral Medications The option of None means the patient did not receive any antiviral drug from the start of the preparative regimen through Day +45 Clinically, this would be highly unusual

9 2100 v 4.0 q Antifungal Medications

10 2100 v 4.0 q Anti-pneumocystis Medications

11 Why the change Understanding the anti-microbial medications at the time of transplant is useful to understand subsequent infections Pros: Data is discrete (single drug) Can use to study prophylaxis patterns Cons: Doesn t provide information on changes in prophylaxis or therapy within an individual patient

12 Infection Reporting Changes: Organism list updated Focused on viral and fungal infections Rare/serious bacterial infections Site list refined Addition of questions for SIRS and Septic Shock Manual updated What not to report Examples

13 Infection reporting

14

15 Bacterial Organisms: 2100 v4.0 Acinetobacter Bordatella pertussis Burkholderia cepacia Campylobacter Capnocytophaga Chlamydia pneumoniae Citrobacter Clostridium (not difficile) Clostridium difficile Corynebacterium jeikeium Enterobacter Enterococcus (VRE) Enterococcus (not VRE) Escherichia/E. coli Fusobacterium Haemophilus influenzae Haemophilus non-influenzae Klebsiella Lactobacillus Legionella pneumophilia Legionella non-pneumophilia Leptospira Leptotrichia buccalis Leuconostoc Listeria Micrococcus Mycobacterium abscessus Mycobacterium avium intracellulare (MAI) Mycobacterium cheloneae Mycobacterium fortuitum Mycobacterium haemophilum Mycobacterium kansasii Mycobacterium marinum Mycobacterium mucogenicum Mycobacterium Tb Mycoplasma Neisseria gonorrhea Neisseria meningitidis Nocardia Pasteurella multocida Proteus Pseudomonas aeruginosa Pseudomonas non-aeruginosa Rhodococcus Rickettsia Salmonella Serratia marcescens Shigella Staphylococcus aureus (Methicillin Resistant) Staphylococcus aureus (Methicillin Sensitive) Stenotrophomonas maltophilia Stomatococcus Streptococcus, alpha-hemolytic Streptococcus, Group B Streptococcus pneumoniae Treponema (syphillis) Vibrio (all spp) Removed several bacterial organisms we are unlikely to study

16 Viral Organisms: 2100 v4.0 Adenovirus BK Virus Coronavirus CMV Chikaungunya Dengue Enterovirus (ECHO, Coxsackie) Enterovirus D68 (EV-D68) Enterovirus (polio) Enterovirus NOS EBV Hepatitis A Hepatitis B Hepatitis C Hepatitis E Herpes Simplex HHV-6 HIV 1/HIV 2 Human metapneumovirus HPV HTLV 1/2 Influenza NOS Influenza A Influenza B JC Virus Measles (rubeola) Mumps Norovirus PML Parainfluenza RSV Rhinovirus Rotavirus Rubella Varicella WNV Several new viruses added Split out certain viruses into 2 categories based upon infections

17 Fungi and Parasites: 2100 v4.0 Fungi Aspergillus NOS Aspergillus flavus Aspergillus fumigatus Aspergillus niger Aspergillus terreus Aspergillus ustus Blastomycosis Candida albicans Candida non-albicans Coccidiomycosis Cryptococcus gattii Cryptococcus neoformans Fusarium spp Histoplasmosis Mucormycosis Pneumocystis Rhizopus Scedosporium Zygomycetes, NOS Suspected Fungal Infection Parasites Chaga's Cryptosporidium Giardia Helminths Strongyloides Toxoplasma Combined all Candida spp into 2 groups Expanded out Aspergillus Added new organisms of importance

18 Sites of Infection (prior) **Disseminated infections must have the organism identified at 3 or more non-contiguous sites

19 Site: Changes 2100 v4 Blood Bone CNS Eyes Genital GI tract, upper GI tract, lower Joints Liver/Spleen Lung Skin/Cellulitis Skin, necrotizing fasciitis Sinuses/Upper respiratory tract Urinary tract, upper Urinary tract, lower

20 SIRS/Septic Shock SIRS: a clinical syndrome of dysregulated inflammation with 2 or more abnormalities in temp, HR, RR, or WBC Does not have to have an organism identified May also be labeled sepsis Septic Shock: Sepsis (life-threatening organ dysfunction) associated with circulatory collapse requiring vasopressors and a lactate of >2 mmol/l associated with an infection Does not have to have an organism identified Higher risk of death compared to SIRS/Sepsis alone

21 What not to report at all! Culture negative neutropenic fever Note: if SIRS/sepsis or Septic Shock occurred, this will be reported separately Suspected but unconfirmed viral or bacterial infections Includes URI presumed viral but no virus identified Candida spp found only in oropharynx or stool Toe nail fungus (onychomycoses)

22 What not to report because it s the same infection: Bacteria Virus Fungal 7 days All bacteria (except Clostridium Difficile) 30 days Clostridium Difficile 365 days Helicobacter pylori 14 days Adenovirus Enterovirus Herpes/Varicella zoster Influenza virus Parainfluenza Rhinovirus Respiratory syncytial virus 60 days Cytomegalovirus Herpes simplex virus Polyomavirus Epstein-Barr virus 14 days Yeasts Candida spp Cryptococcus 90 days Molds Aspergillus Fusarium Mucor

23 Additional changes in process Revisions to 2046/2146 Fungal Infection forms (planned ~April 2017) Additional forms Respiratory virus form 2149 (~April 2017) CMV/HHV-6/EBV/Adenovirus forms (~July 2017) Planned: Revisions to 2047/2147 Hepatitis viral forms Revisions to 2048/2148 HIV forms Addition of PJP form

24 2046/2146 Changes Need data regarding diagnostic testing Allows for researchers to categorize infections as possible/probable/proven Need data regarding treatment Set specific times for assessment of drugs Only request start date Form 2146 required for any fungal infection (including suspected) reported on 2100/2200

25 Form 2046/2146: Diagnostic tests Mark if the test was considered positive to support the diagnosis of fungal infection Sections for: Radiology (CXR, CT scan, MRI) Pathology (biopsy or cytology) Cultures Stains (KOH/Calcofluor/Giemsa) Assays (Galactomannan, Fungitell) Under the test type, specific sites/sample sources requested Set up as skip patterns with the ability to copy and paste to report multiple sites within a specific test

26 Form 2046/2146: Diagnostic tests (ex)

27 Form 2146: Lab data Request data on specific labs at the date of diagnosis of the infection (+/- 7 days) Blood counts WBC % neutrophils % lymphocytes % monocytes Platelets

28 Form 2046/2146: Treatment Request data on all antifungal medications (list provided) from 7 days prior to the diagnosis of the infection until the end of the reporting period Request start date 2046: Note this may be unknown 2146: Generally the HCT center is involved so should be able to find/estimate For each drug received, asks if the patient is still receiving the drug 30 days (+/-3) from date of diagnosis

29 Form 2046/2146: Treatment Only for 2146

30 Form 2046/2146: Response to Therapy Form 2046 Form 2146

31 Form 2149: Respiratory Virus Form Triggered in the following circumstances: Organism of either RSV, PIV, Influenza NOS/A/B or metapneumovirus Organism Rhinovirus or Coronovirus only if the site of infection includes LUNG Rationale: Respiratory viruses can be fatal in the immunocompromised patient Data to understand in our patient population is needed Goal: Collect information on diagnosis, risk factors, and treatment/response to therapy

32 Form 2149: Diagnosis Collect information on tests with a positive result supporting the diagnosis Tests performed 7 days before and up to 14 days after the reported date of infection Allows us to have global picture of certainty of diagnosis

33 Form 2149: Diagnosis

34 Form 2149: Clinical Factors Lab parameters (+/- 7 days of infection diagnosis) WBC, % neutrophils, % lymphocytes, % monocytes, platelets IgG level

35 Form 2149: Therapy and Response Specific antiviral drugs from 7 days prior to date of infection until 14 days after diagnosis IVIG use: y/n

36 Form 2150: CMV/EBV/ADV/HHV-6 Triggered in the following circumstances: Organism of ADV or EBV, regardless of site Organism CMV or HHV-6 if at any site other than just blood Rationale Serious infections that need additional study Goal: Collect information on diagnosis, risk factors, and treatment/response to therapy

37 Form 2150: Diagnosis Collect information on tests with a positive result supporting the diagnosis Tests performed 7 days before and up to 14 days after the reported date of infection Allows us to have global picture of certainty of diagnosis Because of the range of infections, there are several questions but the skip pattern is built into the form

38 Form 2150: Diagnosis

39 Form 2150: Symptoms at diagnosis Symptoms +/- 1 day of diagnosis O2 requirement: y/n Liver/spleen/LN enlargement: y/n (for each) Diarrhea (y/n) Neurologic symptoms (y/n) Lab parameters (+/- 7 days of infection diagnosis) WBC, % neutrophils, % lymphocytes, % monocytes, platelets IgG level Creatinine, ALT (SGPT)

40 Form 2150: Treatment Request data on all antiviral medications (list provided) from 7 days prior to the diagnosis of the infection until the end of the reporting period Date medication started If therapy was still being received 30 days (+/- 3 days) from diagnosis.

41 Form 2150: Treatment and Response Include information on chemotherapy, immunotherapy, IVIG, virus specific T cells If CTLs given, will trigger Form 4000

42 Summary Infection data is important to continue to improve post-hct outcomes for our patient The data you provide is critical, particularly for the rare and/or serious infections