Challenges in conducting trials for pediatric tuberculous meningitis: lessons from the field.

ABSTRACT: SETTING: TBM-KIDS is a phase I/II trial enrolling children with tuberculous meningitis (TBM) in three tertiary referral centers in India and Malawi.OBJECTIVE: To describe the challenges encountered in conducting the first randomized clinical trial of antimicrobial agents in pediatric TBM.DESIGN: The sources of the data were primarily monthly trial reports, non-enrollment case report forms, study diaries and registers maintained for recruitment, experiences shared by key team members during regular study calls and comments from site review visits. We reviewed, broadly categorized, and describe in detail the challenges encountered by study teams in trial implementation.RESULTS: Over 17 months, 3371 children with clinical presentations consistent with meningoenceph

SUBMITTER: Paradkar M 

PROVIDER: S-EPMC9635884 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature