Overview

Study of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant Tuberculosis

Status:
Not yet recruiting

Trial end date:
2025-06-01

Target enrollment:

Participant gender:

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).

Phase:

Phase 1

Details

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Global Alliance for TB Drug Development (TB Alliance)
National Institute of Mental Health (NIMH)