Could a 2-Month TB cure replace 6 months of pills for kids?
NCT ID NCT06253715
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 860 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Sep 2027
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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0 days 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: * 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.
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The places running it
9 sites in 7 countries. 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
Locations
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Africa Health Research Institute (AHRI)
RECRUITINGDurban, South Africa
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Arthur Davison Children's Hospital
RECRUITINGNdola, Zambia
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Dr. D.Y. Patil Medical College, Hospital and Research Center
RECRUITINGPune, India
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Faculty of Medicine, Universitas Padjadjaran
RECRUITINGBandung, Indonesia
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Harare Health and Research Consortium (HHRC)
RECRUITINGHarare, Zimbabwe
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Indian Council of Medical Research - National Institute for Research in Tuberculosis
RECRUITINGChennai, India
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Instituto Nacional de Saúde (INS)
RECRUITINGMaputo, Mozambique
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MU-JHU Care Ltd
RECRUITINGKampala, Uganda
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University of Zambia, School of Medicine
RECRUITINGLusaka, Zambia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Experimental tracer maps lung scarring in TB
- Can a Once-Daily HIV pill with food match Twice-Daily dosing during TB treatment?
- Can a 4-Month drug cocktail cure TB as well as 6 months?
- Can simple sputum and urine tests catch tuberculosis earlier?
- Can a common virus be turned into a TB vaccine? scientists test VIR-1778
- Fish oil meets TB drugs: can Omega-3 help clear infection faster?