Pediatric Anti-bacterial and Anti-fungal Trials from 2007 to 2015: A Systematic Review of ClinicalTrials.gov
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1 Pediatric Anti-bacterial and Anti-fungal Trials from 2007 to 2015: A Systematic Review of ClinicalTrials.gov Joshua Thaden, MD, PhD Fellow, Infectious Diseases Duke University April 5, 2016
2 Objectives Characterize the current state of pediatric anti-bacterial and anti-fungal clinical trials Identify gaps in the clinical trials enterprise Inform efforts to address disparities in the evaluation and development of pediatric drugs
3 What is ClinicalTrials.gov? Registry and results database of publicly and privately supported clinical studies of human participants conducted around the world Interventional trials of drugs, biologics, or devices initiated after September 27, 2007 are required to register
4 Generating the dataset
5 Generating the dataset Algorithm Study Type Registration date, Study start year Enrollment status, Planned or actual # of participants Planned or actual completion year for collection of primary endpoint Planned or actual study duration Eligibility (age ranges, healthy volunteers) # of sites, locations Regulatory / oversight authority, lead sponsor, funding source Intervention type Results reported Manual Review Antibacterial or Antifungal study Infection type Scientific question addressed Outcome measures and data types Study Interventions Conducted under PREA or BPCA Results publication in a Peer- Reviewed journal
6 Anti-bacterial pediatric drug trials Infection type Number (%) studies N=110 Number (%) participants N=23,773 Otitis media 25 (23) 8179 (34) Pneumonia 16 (15) 2353 (10) Skin 10 (9) 3343 (14) Intra-abdominal 9 (8) 1377 (6) Urinary tract infection 6 (5) 3252 (14) Sepsis 6 (5) 1073 (5) CNS 2 (2) 52 (<1) Bacteremia/CLABSI 1 (1) 75 (<1) Other 40 (36) 8760 (37) Very low numbers of CNS and bacteremia/clabsi trials
7 Anti-fungal pediatric drug trials Infection type Number (%) studies N=33 Number (%) participants N=4877 Candidiasis 12 (36) 886 (18) Invasive fungal infections 10 (30) 3034 (62) Skin 4 (12) 2164 (44) Bacteremia/CLABSI 2 (6) 45 (1) Urinary tract infection 1 (3) 2000 (41) Sepsis 1 (3) 145 (3) Pneumonia 0 (0) 0 (0) Intra-abdominal 0 (0) 0 (0) CNS 0 (0) 0 (0) Otitis media 0 (0) 0 (0) Other fungal infections 8 (24) 668 (14) Trials involve primarily candidiasis and invasive fungal infections
8 # studies started Studies per year Anti-bacterial Anti-fungal Year No major increases in anti-bacterial or anti-fungal trials
9 % trials enrolling age group Age enrollment criteria days old 31 days-2 years old >2-6 years old >6-12 years old >12-21 years old Anti-bacterial Anti-fungal Few studies are enrolling neonates
10 Study characteristic Study size Anti-bacterial N=110 n (%) Anti-fungal N=33 n (%) Planned or actual number of participants Mean (SD) 216 (293) 148 (355) Median (25th, 75th) 70 (35, 331) 42 (21, 90) Min, Max 0, , 2000 Number of sites Single site 25 (25%) 6 (21%) Multiple sites 74 (75%) 23 (79%) Anti-bacterial trials are larger than anti-fungal trials
11 Percent funded / sponsored Study sponsor and funding Lead sponsor Funding source Industry NIH Other Anti-bacterial Anti-fungal Anti-bacterial Anti-fungal Industry is sponsoring and funding the majority of studies
12 Pharmacokinetics Infection type Anti-bacterial N=110 n (%) Anti-fungal N=33 n (%) PK sampling None 65 (59%) 15 (45%) (12%) 3 (9%) (3%) 1 (3%) (5%) 4 (12%) Variable 1 (1%) 1 (3%) Number not reported 22 (20%) 9 (27%) PK source matrix No PK sampling 65 (59%) 15 (45%) CSF 5 (5%) 0 (0%) Dried blood spot 2 (2%) 1 (3%) Plasma 45 (41%) 18 (55%) Serum 1 (1%) 1 (3%) Urine 2 (2%) 1 (3%) Stool 1 (1%) 0 (0%) PK sampling generally involves a small number of samples from the plasma
13 Duration of drug trials % Studies Anti-fungal trials take longer Months from study start Anti-bacterial Anti-fungal
14 Reporting results to CT.gov or through scientific literature Low frequency of reporting trial results to ClinicalTrials.gov or through scientific publication
15 Big picture points Overall number of pediatric anti-bacterial and anti-fungal drug trials is low No clear upward trend in number of trials per year Few studies enrolling neonates Industry sponsored and funded the majority of trials
16 Next steps Link this data from ClinicalTrials.gov to the FDA data regarding BPCA/PREA Manuscript preparation
17 Investigators Stephen Bergin Jamie Roberts Brian Smith Ephraim Tsalik William Yang Statistics Karen Chiswell Entire CTTI Pediatric ID team Thanks
18 Thank you. Joshua Thaden, MD, PhD CONNECT WITH CTTI
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Summary 6/4/2018 9:43:09 PM. Differences exist between documents.
Summary 6/4/2018 9:43:09 PM Differences exist between documents. New Document: FDA Guidance - cuti (June 2018, Revision 1 (ucm070981) 19 pages (274 KB) 6/4/2018 9:43:05 PM Used to display results. Old