NCT07656012Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Multi-arm, Open-label, Duration-randomized, Phase IIc Study of the Efficacy, Safety, Tolerability, and Pharmacokinetics of Optimized Rifampicin in Combination With Isoniazid, Pyrazinamide, and Ethambutol for the Treatment of Children With Drug-susceptible Tuberculosis
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
Current tuberculosis (TB) treatment is effective (works well), but it takes a long time to cure TB. This study will evaluate if TB treatment with a higher dose of rifampicin, one of the TB medicines, and shorter TB treatment duration is as effective and safe as the standard, TB treatment (with the usual rifampicin dose and usual duration). This study hopes to find a better shorter treatment that works as well as the current treatment (standard of care). This could benefit children worldwide who are getting TB treatment. Children 3 months to less than 10 years of age who have drug-susceptible TB (can be successfully treated with standard TB medicines) are eligible for this study.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 230 (estimated)
- First submitted
- 15 May 2026
- Start date
- 1 Feb 2027
- Primary completion date
- 28 Feb 2031
- Lead sponsor
- University of Wisconsin, Madison
- Diseases
- Tuberculosis
- NCT number
- NCT07656012
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 230
- From 1 Feb 2027 to the primary completion date, 28 Feb 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received routine treatment for TB disease for greater than 5 days at the time of enrollment
- Exposure to a case of intrathoracic TB in the 12 months prior to enrollment with known or suspected resistance to any of the drugs in the treatment regimens OR confirmed resistance on molecular or phenotypic drug-susceptibility testing to any drugs in the treatment regimens
- Use of any prohibited drug within 3 days of enrollment
- For Main Trial (Step 2) participants, previously enrolled in the Lead-in PK Study (Step 1)
Other illness
- Severe renal, pulmonary, cardiac, gastrointestinal, neurologic or any other condition that in the judgement of the investigator would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives
- Hypersensitivity to any of the study drugs (rifampicin, isoniazid, pyrazinamide or ethambutol)
Lab values
- Has greater than or equal to grade 3 results of any of the following during screening: creatinine, serum ALT, AST, total bilirubin
- Has hemoglobin less than 7.5 g/dL during screening
Age
- Severe acute malnutrition defined as weight-for-height/length z-score or BMI-for-age z-score less than -3
Other
- Has TB meningitis, osteoarticular TB, or miliary TB as determined by the site investigator
Who the study is looking for
- 3 months to less than 10 years of age
- Body weight greater than or equal to 3 kilograms (kg) and less than 45 kg at study entry
- Confirmed or clinically diagnosed intrathoracic (pulmonary) and/or some forms of extrathoracic (extrapulmonary) drug-susceptible TB:
- Confirmed intrathoracic (pulmonary) TB, based on chest radiograph and/or symptoms consistent with TB, and/or some forms of extrathoracic TB, with all of the following as determined by the site investigator:
- Microbiological confirmation of M. tuberculosis from any clinical specimen by either culture or molecular methods
- At least rifampicin-susceptibility demonstrated by genotypic (molecular) or phenotypic methods
- Documented clinical decision to treat for drug-susceptible TB
- Clinically diagnosed intrathoracic (pulmonary) TB, based on chest radiograph and/or symptoms consistent with TB, and/or some forms of extrathoracic TB, with all of the following as determined by the site investigator:
- Documented clinical decision to treat for drug-susceptible TB
- HIV positive or negative
- For participants living with HIV, they must be on a dolutegravir-based antiretroviral therapy regimen at the time of study entry
Age in the registry: 3 months to 9 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Socios en Salud Sucursal Peru Coordinator of this site? Confirm its status | Lima | Peru | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.