Investigating the safety and effectiveness of a new tuberculosis treatment for children.
PHASE I STUDY OF PHARMACOKINETICS, SAFETY AND ACCEPTABILITY OF A SINGLE DOSE OF PRETOMANID ADDED TO AN OPTIMIZED BACKGROUND REGIMEN IN CHILDREN WITH RIFAMPICIN RESISTANT TUBERCULOSIS IMPAACT 2034
This study is looking at how well a new medicine called pretomanid works for kids with a tough type of tuberculosis, checking how safe it is and how kids feel about taking it, while making sure they get great care throughout the process.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Westat, INC. NIH-funded |
| Lab location | 1 site (Rockville, United States) |
| Project ID | NIH-10679271 on NIH RePORTER |
What this research studies
This research focuses on evaluating the pharmacokinetics, safety, and acceptability of a single dose of pretomanid when added to an optimized treatment regimen for children suffering from rifampicin-resistant tuberculosis. The study aims to gather data on how well the drug works in children, its safety profile, and how it is accepted by young patients. By participating, children will receive close monitoring and care as part of a clinical trial designed to improve treatment outcomes for this challenging condition.
Who could benefit from this research
Good fit: Ideal candidates for this research are children aged 0 to 11 years who have been diagnosed with rifampicin-resistant tuberculosis.
Not a fit: Patients who do not have rifampicin-resistant tuberculosis or are older than 11 years may not benefit from this research.
Why it matters
Potential benefit: If successful, this research could lead to more effective treatment options for children with rifampicin-resistant tuberculosis.
How similar studies have performed: Other research has shown promise in using similar approaches for treating tuberculosis, indicating potential for success in this area.
Where this research is happening
Rockville, United States
- Westat, INC. — Rockville, United States (Active)
Researchers
- Principal investigator: Driver, Barbara — Westat, INC.
- Study coordinator: Driver, Barbara
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.