Could a higher dose of rifampicin cut TB treatment time for kids?
NCT ID NCT07656012
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a higher dose of the drug rifampicin can safely shorten tuberculosis treatment for children aged 3 months to 10 years. About 230 children with drug-susceptible TB will receive either the standard or a higher rifampicin dose, with treatment duration adjusted. The goal is to find a shorter regimen that works as well as the current standard, potentially improving outcomes for children worldwide.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Rifampicin (higher dose) combined with isoniazid, pyrazinamide, and ethambutol
- What this could lead to
- If successful, this could lead to a shorter, more convenient treatment for children with tuberculosis, reducing the burden on families and healthcare systems.
- What could go wrong
- This is a Phase 2 trial with only 230 children, so results are preliminary. Higher doses may cause more side effects, and shorter treatment might not cure everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 230 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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3 months to 9 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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 * Has TB meningitis, osteoarticular TB, or miliary TB as determined by the site investigator * 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 * Use of any prohibited drug within 3 days of enrollment * Severe acute malnutrition defined as weight-for-height/length z-score or BMI-for-age z-score less than -3 * Hypersensitivity to any of the study drugs (rifampicin, isoniazid, pyrazinamide or ethambutol) * For Main Trial (Step 2) participants, previously enrolled in the Lead-in PK Study (Step 1)
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Socios en Salud Sucursal Peru
Lima, Peru
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- Can a 4-Drug combo cut TB treatment time in half?