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 between 18 and 65 years old, of any gender
• People whose symptoms and/or chest X-ray or CT scan results support a diagnosis of active pulmonary (lung) tuberculosis (TB)
• People whose TB has been confirmed by laboratory testing (such as a test called GeneXpert), whether or not the TB bacteria show resistance to a common TB drug called rifampicin
• People who are willing to sign a consent form and attend follow-up appointments as required by the trial
• People who are willing to have an HIV test as part of the trial
• People who are willing to have biological samples, including DNA, stored for research purposes
• Women who are able to become pregnant must have a negative pregnancy test within 3 days before joining, and must agree to use an effective form of contraception (such as condoms, an intrauterine device, a cervical cap with spermicide, or a diaphragm with spermicide) throughout the study period
• Women who cannot become pregnant must have documented records of menopause, hysterectomy, removal of both ovaries, or permanent tubal ligation

Who may not be able to join:

• People who have previously been diagnosed with active pulmonary TB and have already received TB treatment (including standard or second-line TB medications)
• People who are known to be intolerant or allergic to any of the study drugs being investigated (bedaquiline, linezolid, certain antibiotics in the fluoroquinolone family including moxifloxacin, or pyrazinamide)
• People whose TB bacteria have been shown by testing to be resistant to any of the study drugs (bedaquiline, linezolid, fluoroquinolones including moxifloxacin, or pyrazinamide)
• People who have TB that has spread through the bloodstream, or who have TB affecting parts of the body outside the chest (note: TB affecting the lungs, the lining around the lungs, the airways, or nearby lymph nodes in the chest is still considered within scope — confirm with trial site if unsure)
• People who have a lung infection caused by bacteria other than TB that could affect their treatment results
• People currently taking medications that would interfere with the study drugs or that cannot safely be combined with them
• People who have been taking immune-suppressing medications or steroid tablets for more than 2 weeks before their screening appointment
• People currently taking, or planning to take, medications known to affect the electrical activity of the heart in a way that could be dangerous — examples listed include amiodarone, amitriptyline, chloroquine, chlorpromazine, cisapride, dipyridamole, itraconazole, procaine, quinidine, or sotalol
• People with diabetes whose blood sugar levels are poorly controlled and are unlikely to improve according to the trial doctors' assessment
• People who test positive for HIV
• People with serious autoimmune diseases, severe liver or kidney problems, psychiatric conditions, blood disorders, or cancer
• People whose recent blood test results (within the past 14 days) fall outside certain safety limits, including liver enzyme levels, kidney function, haemoglobin (a measure of red blood cells), platelet count, or potassium levels (confirm specific values with trial site)
• People whose heart electrical activity reading (ECG) shows a measurement called QTcF of 450 milliseconds or more, or who have risk factors for heart rhythm problems such as irregular heartbeat or reduced blood flow to the heart, or who have a personal or family history of a condition called long QT syndrome (one repeat ECG test may be allowed during screening — confirm with trial site)
• Women who are pregnant or currently breastfeeding
• People who weigh less than 30 kg or 90 kg or more
• People who have participated in another clinical drug trial within the past 3 months
• People considered unsuitable for any other reason, as determined by the trial doctors

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