drugset / Trial / NCT03568383
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Phase 3
Active not recruiting
5832 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabOtsuka Pharmaceutical Development & Commercialization, Inc. · collab
RandomizedParallel-groupOpen-labelPrevention
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.
Timeline
- Start
- 2019-06-03
- Primary completion
- 2027-01-11
- Completion
- 2027-01-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Delamanid | Small molecule | 200 mg | Oral |
| Subject | Isoniazid | Small molecule | 300 mg | Oral |