Phase 3 Tuberculosis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 14 years or older
• People weighing at least 30 kg
• People who are able to sign a written consent form (for those under 18, both the young person's agreement and a parent or guardian's consent are required)
• People with a confirmed lung tuberculosis (TB) diagnosis, shown by a specific test called Xpert MTB/RIF Ultra with a low, medium, or high result
• People whose TB has been confirmed by the same test to be resistant to the antibiotic rifampicin
• People whose chest X-ray shows signs of active TB disease
• People who are able to provide a sputum (mucus coughed up from the lungs) sample
• People of childbearing potential who are willing to use two different approved methods of contraception throughout the treatment period and for 12 weeks after the last dose
• People who are willing to have an HIV test (unless a positive HIV result has already been previously confirmed)
• People who are HIV-positive and have been on a stable HIV treatment regimen (containing dolutegravir, lamivudine or emtricitabine, and tenofovir) for at least 3 months, with a very low level of HIV in the blood and an adequate immune cell count (confirm details with trial site)

Who may not be able to join:

• People whose TB is known or suspected to already be resistant to certain study medications used in the trial (confirm with trial site)
• People who have previously been treated with certain specific TB medications for one month or more within the past three months (confirm with trial site)
• People who have severe TB that has spread outside the lungs
• People whose blood test results fall outside acceptable ranges, including signs of liver stress, reduced kidney function, low red blood cells, low platelets, low white blood cells, or poorly controlled blood sugar (confirm specific values with trial site)
• People who already have nerve damage in their hands or feet, inflammation of the optic nerve, or existing vision problems
• People who are currently enrolled in another clinical treatment trial
• People whose heart electrical activity, measured by an ECG, shows a reading above a certain threshold (confirm with trial site)
• People with significant heart or cardiovascular conditions
• People with bleeding disorders
• People with conditions that would make it difficult to assess their chest X-ray or sputum sample
• People with known allergies or sensitivities to the medications used in this trial
• People who are pregnant or breastfeeding
• People who return a positive result on a drug screening test (each case may be assessed individually for some substances)
• People with serious mental health conditions
• People whose general health and ability to function is assessed as significantly reduced using a standard health scoring tool (confirm with trial site)
• People with a body mass index (a measure of weight relative to height) below 16.0
• People with significant other health conditions affecting the kidneys, liver, digestive system, nervous system, metabolism, or hormonal system
• People with lung conditions other than TB, such as silicosis or lung scarring (fibrosis)
• People with an active COVID-19 infection
• People currently taking medications that are not permitted in this trial
• People who have donated blood or plasma within the past 30 days
• People currently using herbal remedies or traditional medicines

Important: Always verify eligibility with the trial site directly before applying.