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:

• You have been diagnosed with a type of tuberculosis (TB) that is resistant to a common TB drug called rifampicin, but is still treatable with a class of antibiotics called fluoroquinolones, confirmed by a lab test.
• You are 14 years old or older.
• You have a stable home address that can be visited, and you are willing to allow home visits and phone calls, and to let the study team know if you move during the study.
• You are able and willing to sign a consent form (or, if you are a child, a parent/guardian can sign on your behalf with your agreement).
• You have had an HIV test within the last 30 days showing you do not have HIV, or you have documented proof of your HIV status at any point before joining.
• If you have HIV: your immune cell count (CD4+) is at least 50 cells/mm³, tested within the last 30 days.
• If you have HIV: you are currently taking, or plan to start by week 8 of the study, an HIV treatment regimen that includes a drug called dolutegravir.
• If you are pregnant: an ultrasound shows a single, healthy pregnancy that is at least 14 weeks along at the time of enrollment.
• You have had a chest X-ray taken within the last 14 days before joining the study.

Who may not be able to join:

• You have a known allergy or bad reaction to any of the TB medications used in this study.
• Your recent blood test results show problems such as: very low white blood cell count, low red blood cell levels (anaemia), signs of liver stress, high bilirubin levels, high creatinine levels (a sign of kidney problems), or any result considered potentially life-threatening (confirm with trial site).
• A recent heart test (ECG) shows your heart's electrical timing (QTcF interval) is 480 milliseconds or longer.
• You have certain heart-related conditions or risk factors, including a heart rhythm disorder called Wolff-Parkinson-White syndrome, certain types of abnormal electrical signals in the heart, a pacemaker, heart failure, certain types of heart block, a very slow heart rate (under 50 beats per minute), a personal or family history of a condition called long QT syndrome, a history of fainting due to heart problems, or a history of irregular heartbeat (other than a common harmless type called sinus arrhythmia).
• You currently have moderate or severe nerve damage in your hands or feet (called peripheral neuropathy), assessed within the last 7 days.
• A recent assessment (within 14 days) shows your overall physical functioning is severely limited, based on a standard health scoring tool (Karnofsky score below 50) (confirm with trial site).
• Your TB is already known to be resistant to any of the specific medicines used in this trial (bedaquiline, pretomanid, delamanid, linezolid, or fluoroquinolones).
• You have taken certain second-line TB drugs for more than 14 days in the past 12 months.
• Your current TB has spread to your brain/spinal cord, bones/joints, or throughout your whole body (miliary/disseminated TB).
• You are taking another medication that cannot be stopped and would interfere with the study drugs.
• You have a medical, psychological, or social situation that the study doctor believes would make it unsafe for you to participate or make it hard to follow the study requirements.
• You are currently enrolled in another treatment-based clinical trial.

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