Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Status:
Recruiting
Trial end date:
2026-09-30
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
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.
Treatments:
Isoniazid Pyridoxal Pyridoxine Vitamin B 6 Vitamin B Complex Vitamins