Phase 2 Tuberculosis Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You must be a boy or girl aged from birth up to (but not including) 18 years old at the time of screening; if you are in the youngest age group and under 6 months old, you must have been born at full term (at least 37 weeks of pregnancy)
- You must weigh more than 3 kilograms and have a healthy weight for your age based on World Health Organization growth charts
- For older age groups only: Girls who could become pregnant may join if they cannot get pregnant naturally, or if they use reliable birth control during TB treatment and for 6 months after stopping the study drug, or if they are not sexually active with males
- For older age groups only: Boys who are sexually active in a way that could lead to pregnancy must use a condom throughout TB treatment and for 3 months after stopping the study drug
- You must have confirmed or suspected drug-resistant tuberculosis (TB) affecting the lungs and/or certain other parts of the body, diagnosed according to international guidelines
- You must be either starting MDR-TB (multi-drug resistant TB) treatment on the first day of the study, or have started it within the past 12 weeks and be willing to adjust it if needed to work with the study drug
- You must be willing to stop taking a specific TB medicine called Rifampicin at least 7 days before the study begins
- You (or your parent/guardian) must agree to HIV testing; in some cases, the child's mother may also need to be tested for HIV
Who may not be able to join:
- You have a serious ongoing health condition or rapidly worsening health (other than HIV) that the study doctor feels would make it unsafe or unsuitable for you to take part
- You are a girl who is pregnant, breastfeeding, or planning to become pregnant during the study or within 6 months of stopping the study drug
- You have drug-resistant TB that has spread to parts of the body other than the lungs, except for swollen lymph nodes or fluid/scarring around the lungs
- You have a significant heart rhythm problem that needs medication, or have risk factors for a specific dangerous heart rhythm condition (such as heart failure, low potassium levels, a personal or family history of a heart condition called Long QT Syndrome, or untreated underactive thyroid)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
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Trial details
Where this trial is recruiting
Primary endpoints
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs); Maximum Plasma Concentration (Cmax); Time to Reach Maximum Plasma Concentration (Tmax); Minimum Plasma Concentration (Cmin); Area Under the Plasma Concentration-time Curve From the Time of Dose Administration up to X Hours (AUCtime-h); Elimination Half-life (t1/2); Area Under the Plasma Concentration-time Curve From the Time of Dose Administration up to 168 Hours [AUC168h]; Volume of Distribution (Vd); Apparent Clearance (CL)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.