At a glance
ClinicalIndex Comparison Record- ✓Pulmonary TB confirmed by sputum positive for Mtb on Xpert within 7 days, with Xpert semiquantitative result of medium or high
- ✓Documented INH and RIF susceptibility by validated molecular test within 7 days
- ✓HIV-1 infection status documented by licensed rapid test, E/CIA, Western blot, antigen, or viral load
- ✓For HIV-positive individuals: CD4+ ≥100 cells/mm3 within 30 days
- ✕More than 7 cumulative days of TB treatment in the 60 days preceding entry
- ✕Current extrapulmonary TB
- ✕QTcF interval >450 ms within 7 days
- ✕History of or ongoing heart failure
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis
In Brief
A Phase 2 clinical trial evaluating Isoniazid, Rifampicin, and 7 other interventions for Pulmonary Tuberculosis. Currently recruiting, targeting 315 participants across 29 sites in 14 countries.
Detailed 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 study treatment (experimental or SOC, based on treatment arm assignment) followed by 18 weeks of SOC continuation phase treatment with 45 participants in each experimental treatment arm and at least 90 participants in the SOC arm.
Study Details
Timeline
Arms & Interventions
* Weeks 1-8: INH 300 mg, RIF 600 mg, PZA weight-based, EMB weight-based * Weeks 9-26: INH 300 mg, RIF 600 mg (or weight-based dosing following WHO guidance)
* Weeks 1-8: BDQ 400 mg for 2 weeks and then 200 mg for 6 weeks, Pa 200 mg, LZD 600 mg * Weeks 9-26: INH 300 mg, RIF 600 mg (or weight-based dosing following WHO guidance)
* Weeks 1-8: BDQ 400 mg for 2 weeks and then 200 mg for 6 weeks, Pa 200 mg, TBI-223 1200 mg * Weeks 9-26: INH 300 mg, RIF 600 mg (or weight-based dosing following WHO guidance)
* Weeks 1-8: BDQ 400 mg for 2 weeks and then 200 mg for 6 weeks, Pa 200 mg, TBI-223 2400 mg * Weeks 9-26: INH 300 mg, RIF 600 mg (or weight-based dosing following WHO guidance)
* Weeks 1-8: BDQ 400 mg for 2 weeks and then 200 mg for 6 weeks, Pa 200 mg, SZD 800 mg * Weeks 9-26: INH 300 mg, RIF 600 mg (or weight-based dosing following WHO guidance)
* Weeks 1-8: BDQ 400 mg for 2 weeks and then 200 mg for 6 weeks, Pa 200 mg, SZD 1600 mg * Weeks 9-26: INH 300 mg, RIF 600 mg (or weight-based dosing following WHO guidance)
Interventions
INH 300 mg will be administered as one tablet orally once daily.
RIF 600 mg will be administered as two 300 mg capsules orally once daily on an empty stomach, 1 hour before or 2 hours after eating a meal.
PZA will be administered as 500 mg tablets, based on weight, orally once daily.
EMB will be administered as 400 mg tablets, based on weight, orally once daily.
BDQ 400 mg will be administered as four 100 mg tablets orally once daily with a meal for the first 2 weeks followed by 200 mg (two 100 mg tablets) orally once daily with a meal for 6 weeks.
Pa 200 mg will be administered as one 200 mg tablet orally once daily with a meal.
LZD 600 mg will be administered as one 600 mg tablet orally once daily.
TBI-223 2400 mg once daily will be administered as four 600 mg tablets orally once daily with a meal.
SZD 1600 mg once daily will be administered as four 400 mg tablets orally once daily with a meal.
TBI-223 1200 mg once daily will be administered as two 600 mg tablets orally with a meal.
SZD 800 mg once daily will be administered as two 400 mg tablets orally once daily with a meal.