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Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients

Study acronym: PHOENIx MDR-TB
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: 5834 to 5832 Primary and study completion dates: Jul 30, 2027 to Jan 11, 2027v49 Show 1 more changeShow less
    • Primary and study completion dates: Jul 30, 2027 to Jan 11, 2027
  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 5610 to confirmed 5834 · Study sites: 32 to 31v48 Show 2 more changesShow less
    • Enrollment target: estimated 5610 to confirmed 5834
    • Study sites: 32 to 31
  3. Study sites: 31 to 32v47
  4. Primary and study completion dates: Sep 30, 2026 to Jul 30, 2027v46
  5. Study sites: 30 to 31v45
Show 43 earlier versionsHide 43 earlier versions
  1. Study sites: 29 to 30v44
  2. Site details revised at 1 of 29 sitesv43
  3. Study sites: 28 to 29v42
  4. Study sites: 27 to 28v41
  5. Site details revised at 1 of 27 sitesv40
  6. Site details revised at 1 of 27 sitesv39
  7. Site contacts updated at 1 of 27 sitesv38
  8. Primary and study completion dates: Oct 15, 2025 to Sep 30, 2026v37
  9. Re-verified, no change to tracked fieldsv36
  10. Secondary endpoints: details revised at 1 of 4 entriesv35
  11. Study sites: 26 to 27v34
  12. Primary and study completion dates: Jun 18, 2025 to Oct 15, 2025v33
  13. Trial status: Active, Not Recruiting to Recruiting Site details revised at 26 of 26 sitesv32 Show 1 more changeShow less
    • Site details revised at 26 of 26 sites
  14. Study sites: 25 to 26v31
  15. Trial status: Recruiting to Active, Not Recruiting Site details revised at 25 of 25 sitesv30 Show 1 more changeShow less
    • Site details revised at 25 of 25 sites
  16. Eligibility criteria shortened, about 8 wordsv29 See this version in full on ClinicalTrials.gov ↗
  17. Study sites: 23 to 25v28
  18. Site contacts updated at 1 of 23 sitesv27
  19. Site contacts updated at 1 of 23 sitesv26
  20. Study sites: 22 to 23v25
  21. Study sites: 21 to 22v24
  22. Site contacts updated at 1 of 21 sitesv23
  23. Study sites: 20 to 21v22
  24. Study sites: 19 to 20v21
  25. Study sites: 18 to 19v20
  26. Study sites: 16 to 18v19
  27. Study sites: 13 to 16v18
  28. Study sites: 11 to 13v17
  29. Study sites: 9 to 11v16
  30. Study sites: 8 to 9v15
  31. Study sites: 6 to 8v14
  32. Collaborators: 1 to 2v13 See this version in full on ClinicalTrials.gov ↗
  33. Study sites: 5 to 6v12
  34. Primary and study completion dates: Apr 10, 2023 to Jun 18, 2025 Study sites: 4 to 5v11 Show 1 more changeShow less
    • Study sites: 4 to 5
  35. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 18, 2019 to Jun 3, 2019 · Site details revised at 4 of 4 sitesv10 Show 2 more changesShow less
    • Start date changed from estimate of Jun 18, 2019 to Jun 3, 2019
    • Site details revised at 4 of 4 sites
  36. Primary and study completion dates: Jun 18, 2025 to Apr 10, 2023v9
  37. Study sites: 3 to 4v8
  38. Study sites: 2 to 3v7
  39. Primary and study completion dates: Dec 22, 2024 to Jun 18, 2025v6
  40. Study sites: 1 to 2v5
  41. Start date: Mar 15, 2019 to Jun 18, 2019 Study sites: 0 to 1v4 Show 1 more changeShow less
    • Study sites: 0 to 1
  42. Start date: Nov 2018 to Mar 15, 2019v3
  43. Eligibility criteria expanded, about 97 words Study description expanded, about 3 wordsv2 Show 1 more changeShow less
    • Study description expanded, about 3 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.
The purpose of this study is to compare the efficacy and safety of 26 weeks of delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing confirmed or probable active tuberculosis (TB) during 96 weeks of follow-up among high-risk household contacts (HHCs) of adults with multidrug-resistant tuberculosis (MDR-TB) (index cases). High-risk HHCs are those with HIV or non-HIV immunosuppression, latent TB infection, and young children below the age of 5 years.
Trial Details
NCT Number NCT03568383
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions Tuberculosis, MDR
Enrollment 5,832 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov