Phase 2 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 to 65 years, male or female
• People who weigh between 40 kg and 90 kg
• People who have been clinically confirmed to have pulmonary tuberculosis (TB) that has been tested and shown to be resistant to at least the antibiotic rifampicin, with those test results obtained within the past 3 months
• People whose sputum (mucus coughed up from the lungs) tests positive for TB bacteria at a certain level on at least one or two tests
• People currently taking any anti-TB medications who agree to stop all such treatment and complete a 7-day clearance period before the trial begins
• Women of reproductive age who agree to use highly effective contraception throughout the study and for at least 6 months after stopping the study drug; and male participants whose partners could become pregnant who agree to use appropriate contraception for the same period (specific methods are outlined in the trial protocol)
• People who fully understand the purpose and requirements of the trial and voluntarily sign a written consent form agreeing to follow its conditions

Who may not be able to join:

• People who are unable to take the study medications delamanid, bedaquiline, or linezolid for any reason
• People who have already taken delamanid, bedaquiline, or linezolid for more than 1 month, unless test results show no resistance to those drugs
• People whose TB has spread through the bloodstream, or who have severe TB outside the lungs, or who the trial doctor believes may need surgery for their TB within 8 weeks
• People with a personal or family history of a heart rhythm condition called long QT syndrome, or with a history of a dangerous irregular heartbeat called torsades de pointes, or with ongoing underactive thyroid or abnormally slow heart rate
• People who, in the 6 months before joining, have had any of the following: a heart attack; heart surgery or a procedure to open blocked heart arteries; unstable chest pain (angina); severe heart failure; or a mini-stroke or serious stroke
• People with moderate to severe nerve damage in the hands or feet (peripheral neuropathy), or milder nerve damage that the trial doctor believes may get worse during the study, or people with inflammation of the optic nerve (optic neuritis)
• People who have had stomach or bowel surgery that may affect how the body absorbs or processes oral medications
• People with unstable or serious conditions affecting the heart, kidneys, liver, blood, tumours, hormones and metabolism, mental health, or immune system that the trial doctor considers makes them unsuitable for the trial
• People with a history of alcohol dependence or drug misuse in the 6 months before screening, if the trial doctor believes this may affect their safety or ability to follow the study requirements
• People who have taken part in another clinical trial and received an experimental drug within the past 3 months
• People currently taking medications that suppress bone marrow function
• People currently taking certain antidepressants or related drugs, including serotonin reuptake inhibitors, tricyclic antidepressants, or serotonin receptor drugs
• People currently taking medications known to affect the heart's electrical activity (QT interval), such as quinidine, procainamide, amiodarone, or sotalol
• People who have been taking ongoing steroid tablets for a total of more than 4 weeks in the 3 months before joining
• People who are known or confirmed by the trial doctor to be allergic to any of the study drugs or related substances
• Women who test positive for pregnancy during screening, or who are currently breastfeeding
• People who test positive for hepatitis B with certain markers present; people who test positive for hepatitis C antibodies and also have elevated liver enzyme levels; people who test positive for HIV; or people who test positive for syphilis and have an active syphilis infection
• People whose blood test results show any of the following: very low haemoglobin (below 80 g/L); low platelets (below 75 × 10⁹/L); liver enzyme levels (AST or ALT) more than 3 times the normal upper limit; bilirubin more than 2 times the normal upper limit; creatinine (a kidney marker) more than 1.5 times the normal upper limit; or amylase (a pancreas marker) more than 2 times the normal upper limit
• People whose heart tracing (ECG) shows certain abnormalities, including: a prolonged electrical interval on at least two readings (QTcF above 450 ms for males or 470 ms for females); abnormal Q waves; signs of a condition where electrical signals travel through the heart too early; certain abnormal patterns in how electrical signals travel through the heart; an unusually slow heart rate below 50 beats per minute; or other specified electrical conduction abnormalities (confirm specific ECG criteria with trial site)
• People who, in the trial doctor's judgement, have any condition that may affect their ability to follow the study requirements, or any serious medical or psychological condition that could affect the trial results or their safety during the trial

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