Condition: Pulmonary Tuberculosis · Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
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.
This description comes directly from the study's public registry record.
Radojka Savic, PharmD, PhD · 415-502-0640 · rada.savic@ucsf.edu
Kelly Dooley, MD, PhD · 615-322-8972 · kelly.e.dooley@vumc.org
Always discuss trial participation with your own doctor first.
| 12701, Gaborone CRS | Gaborone, Botswana | Recruiting |
| 12201, Instituto de Pesquisas em AIDS do Rio Grande do Sul - IPARGS CRS | Porto Alegre, Brazil | Recruiting |
| 12101, Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS | Rio de Janeiro, Brazil | Recruiting |
| 30022, Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS | Port-au-Prince, Haiti | Not Yet Recruiting |
| 31730, GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS | Port-au-Prince, Haiti | Not Yet Recruiting |
| 31441, Byramjee Jeejeebhoy Medical College (BJMC) CRS | Pune, India | Not Yet Recruiting |
| 12601, Moi University Clinical Research Center (MUCRC) CRS | Eldoret, Kenya | Recruiting |
| 12501, Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS | Kericho, Kenya | Recruiting |
| 30301, Blantyre CRS | Blantyre, Malawi | Not Yet Recruiting |
| 12001, Malawi CRS | Lilongwe, Malawi | Not Yet Recruiting |
| 32078, Nutrición-Mexico CRS | Mexico City, Mexico | Not Yet Recruiting |
| 11301, Barranco CRS | Lima, Peru | Recruiting |
+ 17 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06192160