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Could a higher dose of rifampicin cut TB treatment time for kids?

NCT ID NCT07656012

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 230 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

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

3 months to 9 years

Sex

Anyone

Healthy volunteers

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

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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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Socios en Salud Sucursal Peru

    Lima, Peru

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