Home › Trials › NCT06253715

Shortened treatment for tuberculosis in children

Shortened Regimen for Drug-susceptible TB in Children

Phase 3 Interventional Johns Hopkins University · NCT06253715

This study is testing if a shorter 2-month treatment for tuberculosis works just as well and is safe for children under 10 as the usual 4- to 6-month treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment860 (estimated)
Ages0 Days to 9 Years
SexAll
SponsorJohns Hopkins University Academic / other
Locations9 sites (Chennai and 8 other locations)
Trial IDNCT06253715 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates whether a 2-month treatment regimen using isoniazid, rifapentine, pyrazinamide, and moxifloxacin is as safe and effective as the standard 4- to 6-month regimen for curing drug-susceptible tuberculosis in children under 10 years old. The study aims to determine if the shorter regimen can improve treatment adherence and reduce caregiver burden. Participants will be children diagnosed with pulmonary or lymph node TB, and the study will assess treatment outcomes and safety, including in children with HIV.

Who should consider this trial

Good fit: Ideal candidates for this study are children under 10 years old diagnosed with drug-susceptible tuberculosis.

Not a fit: Patients with drug-resistant tuberculosis or those who do not meet the age and weight criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the duration of tuberculosis treatment in children, making it easier for them to complete therapy.

How similar studies have performed: Other studies have shown promise with shorter treatment regimens for tuberculosis, but this specific approach in children is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Chennai and 8 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions TuberculosisTuberculosis, PulmonaryTuberculosis, Lymph NodeMycobacterium Tuberculosistuberculosispediatricstratified medicineshortened regimen
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.