drugset / Trial / NCT05586230
Study of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant Tuberculosis
Phase 1
Completed
32 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabGlobal Alliance for TB Drug Development · collabNational Institute of Mental Health (NIMH) · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of the study is to evaluate the pharmacokinetics (PK), safety, tolerability, and acceptability of a single dose of pretomanid, added to an optimized background tuberculosis treatment regimen (OBR), in children with rifampicin-resistant tuberculosis (RR-TB) with or without human immunodeficiency virus (HIV).
Timeline
- Start
- 2023-10-03
- Primary completion
- 2026-04-28
- Completion
- 2026-04-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pretomanid | Small molecule | — | Oral |