Phase 4 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:

• You are at least 19 years old when you sign up for the trial
• You weigh more than 35 kg (about 77 lbs)
• Your TB has been confirmed through a lab test (on a sputum or lung sample taken within the last 3 months) to be resistant to a key TB antibiotic called rifampicin
• A chest X-ray or scan shows signs of TB in your lungs

Who may not be able to join:

• You have diabetes that is not well controlled
• Your TB has spread outside the lungs in a way that would need a longer course of treatment than usual
• You score below 30 on a standard health and ability scale (meaning you are severely unwell and largely unable to care for yourself) — (confirm with trial site)
• Your Body Mass Index (BMI, a measure of body weight relative to height) is below 17
• You have a known serious allergic reaction to any of the medications used in this trial's treatment combination (called BPaLM)
• You have a medical history of certain rare inherited conditions affecting how your body processes sugars, specifically glucose-galactose malabsorption, galactose intolerance, or Lapp lactase deficiency
• You are HIV-positive
• A heart tracing (ECG) at the start of the trial shows a specific measurement of your heart rhythm (QTcF interval) above 450 milliseconds
• You have an underlying heart condition such as heart failure or irregular heartbeat that puts you at risk of a dangerous heart rhythm problem
• You are a woman who could become pregnant and your pregnancy test is positive, you are currently breastfeeding, you are planning to become pregnant within 6 months after finishing the study treatment, or you are unwilling to use two forms of contraception (such as condoms combined with hormonal contraception or an intrauterine device) or abstinence throughout the study and for 6 months after stopping treatment
• You are a man who plans to father a child during the study or within 6 months after finishing treatment, or you are unwilling to use two forms of contraception or abstinence during this time
• You have moderate-to-severe nerve damage in your hands or feet (called peripheral neuritis), or mild nerve damage that is likely to get worse
• You are currently taking, or have taken in the last 2 weeks, a type of antidepressant/medication called a monoamine oxidase inhibitor (MAOI)
• You have taken a certain type of antidepressant that affects serotonin within the last 3 days
• You are taking any medications known to affect heart rhythm in a potentially dangerous way (such as amiodarone, chloroquine, clarithromycin, haloperidol, or similar drugs)
• You are taking any medications that can reduce your bone marrow's ability to produce blood cells
• You have taken certain medications within the last 30 days that affect how the liver processes drugs (a liver enzyme system called cytochrome P450) — (confirm with trial site for the full list of affected medicines)
• You have previously been treated with either bedaquiline or linezolid (two TB medications) for more than 4 weeks
• Your blood test results at the start of the trial show certain abnormal levels, including low potassium, low red blood cell count (haemoglobin below 8.0 g/dL), low platelets, low white blood cells, abnormal liver function, low albumin (a blood protein), poor kidney function, or low calcium or magnesium levels — (confirm specific values with trial site)

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