title: Characteristics of antimicrobial studies registered in the USA through ClinicalTrials.Gov.
abstract: Increasing rates of antimicrobial-resistant infections and the dwindling pipeline of new agents necessitate judicious, evidence-based antimicrobial prescribing. Clinical trials represent a vital resource for establishing evidence of safety and efficacy, which are crucial to guiding antimicrobial treatment decisions. The objective of this study was to comprehensively evaluate the characteristics of antimicrobial research studies registered in ClinicalTrials.gov. Primary outcome measures, funding sources, inclusion criteria and the reporting of study results were evaluated for 16055 antimicrobial studies registered in ClinicalTrials.gov as of mid 2012. Interventional studies accounted for 93% of registered antimicrobial studies. Clinical trials of drugs (82%) and biologics (9%) were most common. Antibacterial, antiviral and antifungal studies accounted for 43%, 41% and 16% of drug trials, respectively. Among interventional drug trials, 73% featured randomised allocation to study arms and 71% included measures of safety and/or efficacy as primary endpoints. Children were eligible for enrolment in 26% of studies. Among the studies, 60% were sponsored primarily by non-profit organisations, 30% by industry and 10% by the federal government. Only 7% of studies reported results; however, 71% of these were sponsored primarily by industry. Antimicrobial studies commonly incorporated elements of high-quality trial design, including randomisation and safety/efficacy endpoints. Publication of study results and updating of ClinicalTrials.gov should be encouraged for all studies, with particular attention paid to research sponsored by non-profit organisations and governmental agencies. Leveraging the application of these data to guide the careful selection of antimicrobial agents will be essential to preserve their utility for years to come.
authors.affiliation: Department of Paediatrics, University of Utah School of Medicine, Salt Lake City, UT, USA. Chris.Stockmann@hsc.utah.edu
authors.forename: Chris
authors.initials: C
authors.lastname: Stockmann
authors.forename: Catherine M T
authors.initials: CM
authors.lastname: Sherwin
authors.forename: Krow
authors.initials: K
authors.lastname: Ampofo
authors.forename: Adam L
authors.initials: AL
authors.lastname: Hersh
authors.forename: Andrew T
authors.initials: AT
authors.lastname: Pavia
authors.forename: Carrie L
authors.initials: CL
authors.lastname: Byington
authors.forename: Robert M
authors.initials: RM
authors.lastname: Ward
authors.forename: Michael G
authors.initials: MG
authors.lastname: Spigarelli
mesh_terms: D000293:Adolescent; D000328:Adult; D000890:Anti-Infective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data; D003141:Communicable Diseases / Q000188:drug therapy*; D016208:Databases, Factual / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D014481:United States; D055815:Young Adult
chemical_list: D000890:Anti-Infective Agents
keywords: Anti-infective agents; Antibacterial; Antibiotic; Antifungal; Antiviral