Could a 2-Month TB cure replace 6 months of pills for kids?

NCT ID NCT06253715

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 24, 2026 · Updated 4 times

Summary

This study tests whether a 2-month combination of four drugs can cure drug-susceptible tuberculosis in children under 10 as safely and effectively as the standard 4- to 6-month regimen. Researchers will enroll 860 children, including those with HIV, to compare the shorter treatment to the usual one. The goal is to make TB treatment easier for children and their families.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
isoniazid, rifapentine, pyrazinamide, moxifloxacin
What this could lead to
If successful, this could offer a shorter, easier-to-tolerate treatment for children with TB, reducing side effects and caregiver burden.
What could go wrong
This is a large phase 3 trial, but the shorter regimen may prove less effective or cause more side effects than the standard treatment. Results are not yet known.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 860 people

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

Started

Jan 2025

Expected to finish

Sep 2027

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

0 days 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: * Parent or guardian is willing and able to provide written informed consent for potential participant's study participation; in addition, when applicable per Ethics Committee/Institutional Review Board (EC/IRB) policies and procedures, potential participant is willing and able to provide assent for study participation. * At Entry, age of less than 10 years. * At Entry, weight 3 kilograms (kg) or greater. * At Entry, diagnosed with TB disease, defined as: * Pulmonary (including pleural effusion) and/or lymph node (extra-thoracic and/or intra-thoracic) TB with or without bacteriologic confirmation; * Clinician has decided to treat with standard first-line drug-susceptible TB regimen. * Known HIV status or HIV testing in progress based on meeting testing requirements. * Has normal, Grade 1 or 2 test results for all of the following done at or within 14 days of Entry (including the most recent): * Alanine aminotransferase (ALT) less than or equal to 5 times the upper limit of normal; * Total bilirubin less than or equal to 2.5 times the upper limit of normal; * Potassium level of 3.0 milliequivalent/L or greater; * Hemoglobin level of 7.0 g/dL or greater; * Platelet count of 100,000/mm3 or greater; * Estimated glomerular filtration rate (eGFR; bedside Schwartz formula) 60 mL/min/1.73m2 or higher. * For children living with HIV: * On antiretroviral therapy (ART) at Entry: Must be on, or able to be switched to a dolutegravir-based regimen at or prior to Entry; * Not on ART at Entry: Planned initiation of dolutegravir before or at study Week 4. * For participants who have reached menarche or who are engaging in sexual activity (self-reported): negative serum or urine pregnancy test within 7 days of Entry. * For participants who are engaging in sexual activity that could lead to pregnancy (self-reported): agrees to practice at least one non-hormonal method of contraception or abstain from heterosexual intercourse during study drug treatment and for 30 days after stopping study medications. Non-hormonal methods include: * Male or female condoms * Diaphragm or cervical cap (with spermicide, if available) * Non-hormonal intrauterine device (IUD) or intrauterine system (IUS) * At Entry, intends to remain in the catchment area of the study site for the duration of study follow-up or willingness to be followed up beyond the catchment area if/when applicable, as determined by the site investigator based on participant/parent/guardian report. Exclusion Criteria: * Presumed or documented extra-pulmonary TB involving the central nervous system and/or bones and/or joints, and/or miliary TB, and/or pericardial TB and/or TB of the gastrointestinal (GI) tract and/or renal TB. * Premature infant (born less than 37-weeks gestation) who is less than 3 months of age at Entry. * Any known contraindication to taking any study drug: * Known allergy or intolerance to any of the study drugs or drugs in the same class as the study drugs; * Any prohibited medications within three days prior to Entry or planned use within the following 6 months; * Unable to take oral medications; * Known history of prolonged QT syndrome not caused by electrolyte derangements. * Received more than 10 days of treatment directed against TB disease within 6 months preceding initiation of study drugs. * M. tuberculosis isolate known or suspected to be resistant to isoniazid, rifampin, pyrazinamide, ethambutol, and/or fluoroquinolones. * Known exposure to an infectious adult with drug-resistant TB, including resistance to isoniazid, rifampin, pyrazinamide, ethambutol, and/or fluoroquinolones. * Has any other documented or suspected clinically significant medical condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives. * Previously enrolled in this study. Late Exclusions: * M. tuberculosis cultured or detected through World Health Organization (WHO) approved molecular assays (e.g., Cepheid Xpert MTB/RIF, Xpert XDR, sequencing or Hain MTB-DR plus assays) from sputum, swallowed sputum, nasopharyngeal aspirates, stool, or lymph node aspirate obtained around the time of study entry is determined to be resistant to isoniazid and/or rifampin and/or pyrazinamide and/or ethambutol and/or fluoroquinolones. * Any child with a clinical TB diagnosis who is found to have a definitive alternative diagnosis for their presenting signs and symptoms whose TB treatment is discontinued prior to completion.

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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 places running it

    9 sites in 7 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Africa Health Research Institute (AHRI)

    RECRUITING

    Durban, South Africa

  • Arthur Davison Children's Hospital

    RECRUITING

    Ndola, Zambia

  • Dr. D.Y. Patil Medical College, Hospital and Research Center

    RECRUITING

    Pune, India

  • Faculty of Medicine, Universitas Padjadjaran

    RECRUITING

    Bandung, Indonesia

  • Harare Health and Research Consortium (HHRC)

    RECRUITING

    Harare, Zimbabwe

  • Indian Council of Medical Research - National Institute for Research in Tuberculosis

    RECRUITING

    Chennai, India

  • Instituto Nacional de Saúde (INS)

    RECRUITING

    Maputo, Mozambique

  • MU-JHU Care Ltd

    RECRUITING

    Kampala, Uganda

  • University of Zambia, School of Medicine

    RECRUITING

    Lusaka, Zambia

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