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Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis

Study acronym: RAD-TB
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 29 to 30 Eligibility criteria expanded, about 51 words · Publications: details revised at 2 of 2 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 51 words
    • Publications: details revised at 2 of 2 entries
  2. Site details revised at 2 of 29 sitesv32
  3. Site details revised at 1 of 29 sitesv31
  4. Site details revised at 3 of 29 sitesv30
  5. Site details revised at 1 of 29 sitesv29
Show 27 earlier versionsHide 27 earlier versions
  1. Site details revised at 2 of 29 sitesv28
  2. Site details revised at 1 of 29 sitesv27
  3. Site details revised at 1 of 29 sitesv26
  4. Site details revised at 1 of 29 sitesv25
  5. Study sites: 28 to 29 Eligibility criteria expanded, about 59 wordsv24 Show 1 more changeShow less
    • Eligibility criteria expanded, about 59 words

    See this version in full on ClinicalTrials.gov ↗

  6. Site details revised at 2 of 28 sitesv23
  7. Site details revised at 1 of 28 sitesv22
  8. Site details revised at 1 of 28 sitesv21
  9. Study sites: 27 to 28v20
  10. Primary completion date: Mar 11, 2026 to Nov 11, 2026 Completion date: Mar 11, 2027 to Aug 11, 2027v19 Show 1 more changeShow less
    • Completion date: Mar 11, 2027 to Aug 11, 2027
  11. Site details revised at 2 of 27 sitesv18
  12. Study sites: 26 to 27v17
  13. Study sites revised (26)v16 See this version in full on ClinicalTrials.gov ↗
  14. Trial status: Suspended to Recruiting Site details revised at 26 of 26 sitesv15 Show 1 more changeShow less
    • Site details revised at 26 of 26 sites
  15. Study sites: 25 to 26v14
  16. Trial status: Recruiting to Suspended Sponsor's reason: Temporarily Closed (Paused) to Accrual Site details revised at 25 of 25 sitesv13 Show 1 more changeShow less
    • Site details revised at 25 of 25 sites
  17. Site details revised at 1 of 25 sitesv12
  18. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 1, 2025 to Mar 11, 2025 · Site details revised at 25 of 25 sitesv11 Show 2 more changesShow less
    • Start date changed from estimate of Mar 1, 2025 to Mar 11, 2025
    • Site details revised at 25 of 25 sites
  19. Study sites: 24 to 25v10
  20. Start date: Jan 10, 2025 to Mar 1, 2025v9
  21. Primary completion date: Jun 10, 2025 to Mar 11, 2026 Completion date: Apr 14, 2026 to Mar 11, 2027v8 Show 1 more changeShow less
    • Completion date: Apr 14, 2026 to Mar 11, 2027
  22. Start date: Oct 15, 2024 to Jan 10, 2025v7
  23. Start date: Sep 15, 2024 to Oct 15, 2024v6
  24. Re-verified, no change to tracked fieldsv5
  25. Start date: Apr 15, 2024 to Sep 15, 2024v4
  26. Collaborators expanded, about 2 wordsv3 See this version in full on ClinicalTrials.gov ↗
  27. Interventions: Bedaquiline (Drug), Ethambutol (Drug), Isoniazid (Drug), Linezolid (Drug), Pretomanid (Drug), Pyrazinamide (Drug), Rifampicin (Drug)… to Bedaquiline (Drug), Ethambutol (Drug), Isoniazid (Drug), Linezolid (Drug), Pretomanid (Drug), Pyrazinamide (Drug), Rifampicin (Drug)… Primary endpoints revised (2) · Study title shortened, about 5 wordsv2 Show 2 more changesShow less
    • Primary endpoints revised (2)
    • Study title shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06192160
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: TB Alliance
Conditions Pulmonary Tuberculosis
Enrollment 315 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov