Improving treatment for isoniazid-resistant tuberculosis
Treatment of isoniazid-resistant tuberculosis: closing evidence gaps on safety, effectiveness, and pharmacokinetics of the standard regimen
This project tests whether replacing isoniazid with levofloxacin and adjusting doses gives safer, more effective treatment for adults with isoniazid-resistant TB.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Socios En Salud Sucursal Peru NIH-funded |
| Lab location | 1 site (Lima, Peru) |
| Project ID | NIH-11120877 on NIH RePORTER |
What this research studies
If you have isoniazid-resistant TB, this project offers a six-month regimen that swaps isoniazid for levofloxacin while keeping rifampicin, ethambutol, and pyrazinamide in the mix. Doctors will collect blood and plasma samples to measure drug levels and may explore higher rifampicin or levofloxacin doses within safety limits. Participants will be monitored for treatment success and for side effects such as liver toxicity during active follow-up in Lima, Peru. The aim is to produce clearer, evidence-based guidance about safety, dosing, and effectiveness for people with this type of resistant TB.
Who could benefit from this research
Good fit: Adults (21 years and older) with pulmonary TB whose Mycobacterium tuberculosis is resistant to isoniazid but remains sensitive to rifampicin are the best candidates.
Not a fit: People with rifampicin-resistant TB, children, or patients unwilling/unable to attend regular clinic visits and blood tests are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, this work could lead to clearer treatment guidelines that improve cure rates and reduce harmful side effects for people with isoniazid-resistant TB.
How similar studies have performed: Guidelines from WHO and CDC already suggest levofloxacin-based regimens based on observational studies and meta-analyses, but high-quality clinical trial data and pharmacokinetic/safety information are currently limited.
Where this research is happening
Lima, Peru
- Socios En Salud Sucursal Peru — Lima, Peru (Active)
Researchers
- Principal investigator: Mendoza, Alberto — Socios En Salud Sucursal Peru
- Study coordinator: Mendoza, Alberto
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.