Clinical Trial

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

Study acronym: PHOENIx MDR-TB
Active, Not Recruiting Phase 3
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Summary
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.
Protocol Amendment History 48 amendments
This ClinicalTrials.gov record has been amended 48 times since 2018-06-14; most recent amendment 2025-06-13.
Status change: Recruiting → Active, Not Recruiting 2025-04-17
Status change: Active, Not Recruiting → Recruiting 2020-07-17
Status change: Recruiting → Active, Not Recruiting 2020-04-18
Status change: Not Yet Recruiting → Recruiting 2019-06-07
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 2019-06-03
Primary Completion 2027-01-11 (estimated)
Study Completion 2027-01-11 (estimated)
Updated on ClinicalTrials.gov 2025-06-15