Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis
Status:
Not yet recruiting
Trial end date:
2026-04-14
Target enrollment:
Participant gender:
Summary
A5409/RAD-TB is an adaptive Phase 2 randomized, controlled, open-label, dose-ranging,
platform protocol to evaluate the safety and efficacy of multidrug regimens for the treatment
of adults with drug-susceptible pulmonary tuberculosis (TB).
A5409 hypothesizes that novel regimens for the treatment of pulmonary tuberculosis will
result in superior early efficacy, as determined by longitudinal mycobacteria growth
indicator tube (MGIT) liquid culture time to positivity (TTP) measurements over the first 6
weeks of treatment, and will have acceptable safety and tolerability over 8 weeks of
treatment relative to standard of care [(SOC) isoniazid/rifampicin/pyrazinamide/ethambutol
(HRZE)].
The study will run for 52 weeks, inclusive of 26 weeks of TB treatment comprised of 8 weeks
of experimental or SOC treatment (based on treatment arm assignment) followed by 18 weeks of
SOC treatment with 45 participants in each experimental treatment arm and at least 90
participants in the SOC arm.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)