RE-evaluating the duration in children of TB treatment (reduce TB): a phase 2 duration randomized trial

The National Institute of Allergy and Infectious Diseases awarded University of Wisconsin–Madison a $4,341,309 cooperative agreement on September 19, 2025, under the Allergy and Infectious Diseases Research program (CFDA 93.855) to conduct a Phase 2 randomized clinical trial evaluating shortened treatment durations for drug-susceptible tuberculosis in children using a high-dose rifampicin regimen combined with standard doses of isoniazid, pyrazinamide, and ethambutol. The trial will randomize participants into four study arms with varying treatment durations and characterize the relationship between duration and favorable treatment response. Performance runs through August 31, 2030, with work performed in Madison, Wisconsin.

Frontier Science & Technology Research Foundation serves as the Data Management Center, implementing data collection systems, ensuring data integrity and security, and providing training and support to study sites and laboratories. Harvard College's Center for Biostatistics in AIDS Research, through sub-grantee President and Fellows of Harvard College, provides statistical leadership on study design, sample size calculations, data monitoring, and interim and final analyses. Rhode Island Hospital, through sub-recipient Brown University affiliation, provides clinical trial oversight at the study site in Lima, Peru, with Dr. Silvia Chiang serving as co-investigator to coordinate activities with Socios En Salud, collaborate on post-treatment lung evaluations, and contribute to qualitative assessment of participant and family experiences with TB treatment.

Abstract

Tuberculosis (TB) remains a major global public health problem in children. In 2022 there were approximately 1.3 million new cases of TB in children