Improving treatment for isoniazid-resistant tuberculosis
Official title: Treatment of isoniazid-resistant tuberculosis: closing evidence gaps on safety, effectiveness, and pharmacokinetics of the standard regimen
Funded at Socios En Salud Sucursal Peru · NIH-11120877 · Data updated 2026-11-12
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 start | June 18, 2024 |
| Project end | May 31, 2029 |
| Funding year | 2025 |
| Award (this year) | $131,016 |
| NIH project number | 5R01AI183405-02 |
| Project ID | NIH-11120877 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults (21 years and older) with pulmonary TB whose Mycobacterium tuberculosis is resistant to isoniazid but remains sensitive to rifampicin are the best candidates.
✕Less likely to help
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.
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.
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 gone: 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
-
Socios En Salud Sucursal Peru
Lima, Peru Active
Researchers
- Principal investigator: Mendoza, Alberto — Socios En Salud Sucursal Peru
- Study coordinator: Mendoza, Alberto
Related research
Other NIH-funded projects on the same topics.
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Urine color test to check tuberculosis drug levels in children and adults
This project uses a simple urine color test to see whether children and adults with TB are getting enough of key TB medicines like rifampin.
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Treatment options for isoniazid-resistant TB: safety, effectiveness, and drug levels with a standard regimen
This grant studies whether a standard TB treatment plan that includes levofloxacin is safe and effective for people with isoniazid-resistant TB in Peru.
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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.