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:

For the index patient (the person with tuberculosis):

• People of any age who have been confirmed with pulmonary tuberculosis (TB affecting the lungs) through laboratory testing
• People who started TB treatment within the past 90 days
• People who have at least one close contact who is likely to meet the study requirements

For people living with HIV (PLHIV) joining the trial:

• People who are on a specific type of HIV medication (dolutegravir-based or another approved integrase inhibitor) that does not interact with the study drugs; people on certain other HIV medication types may be eligible after switching to a compatible regimen for a required period before joining (confirm with trial site)
• People living with HIV who are not yet on HIV medication must have started a compatible HIV treatment regimen before enrolling

For close contacts of someone with TB:

• People who lived in the same home or shared housekeeping arrangements with the TB patient for at least one night in the 90 days before the TB patient started treatment
• People who shared more than four hours of indoor air space with the TB patient during any one-week period in the 90 days before the TB patient started treatment
• Children under 5 years old at the time of enrollment, regardless of TB infection or HIV status
• People aged 5 and older who have tested positive for TB infection (via skin test or blood test) and are HIV-negative, have an unknown HIV status, or have an indeterminate HIV result
• People aged 5 and older who have a documented HIV infection, regardless of TB infection test result

All participants (PLHIV and close contacts) must also meet these requirements:

• Willingness and ability to provide informed consent (a parent or guardian may consent on behalf of a child)
• Documentation of HIV status, confirmed through appropriate testing or records depending on age and testing history (confirm with trial site for specific documentation requirements)
• People living with HIV must be on a compatible HIV medication regimen, as described above
• A chest X-ray taken within the past 30 days showing no signs of active TB disease
• Recent blood test results (within 30 days) showing that liver, kidney, blood cell, and electrolyte (potassium, magnesium, calcium) levels are within acceptable ranges
• A negative pregnancy test within 7 days before enrolling, for people who could potentially be pregnant (those who have started their period, have had a period in the past 24 months, or have not had surgical sterilisation)

Who may not be able to join:

For the index patient:

• People unwilling or unable to provide informed consent
• People with no close contacts likely to be eligible for the study
• Cases where the trial site is unable to determine whether the TB is drug-sensitive or drug-resistant
• People whose TB bacteria have been found to be resistant to the study drug bedaquiline
• People with drug-resistant TB whose bacteria have been found to be resistant to a class of antibiotics called fluoroquinolones

For people living with HIV and close contacts:

• People unwilling or unable to provide informed consent
• People weighing 3 kg or less
• People who currently have confirmed, probable, or possible TB (pulmonary or elsewhere in the body) at the time of enrollment
• People who have previously completed a full course of TB treatment
• People who have previously completed a full course of TB preventive therapy (confirm with trial site for specific regimens)
• People currently enrolled in another therapeutic clinical trial
• People with severe kidney disease or kidney failure requiring dialysis
• People with severe liver disease (classified as Child-Pugh C)
• People showing signs of acute hepatitis (such as stomach pain, yellowing of the skin or eyes, dark urine, or pale stools) in the 90 days before enrollment
• People with a serious heart rhythm problem requiring medication
• People with moderate or severe nerve damage in the hands or feet (Grade 2 or higher)
• People who have ever been diagnosed with a condition called porphyria
• People with a specific abnormal heart rhythm measurement (QTcF greater than 460 milliseconds) on an ECG
• People who are unable to take medication by mouth
• People with serious drug or alcohol use that, in the opinion of the trial site investigator, would make it difficult to follow the treatment schedule
• People who have been hospitalised or required serious medical treatment (including intravenous antibiotics) in the 30 days before enrollment
• People who have previously been treated with the study drugs bedaquiline or clofazimine
• People who have taken more than 7 days total of certain antibiotics (isoniazid, a rifamycin, or a fluoroquinolone) in the 90 days before enrollment
• People whose TB contact (index patient) has been found to have TB bacteria resistant to bedaquiline
• People with a known allergy or sensitivity to the study drugs or their ingredients
• People currently taking another medication that cannot be safely stopped or adjusted and that is not compatible with the study drugs
• People who are pregnant or breastfeeding

Additional exclusions for close contacts of someone with drug-resistant TB:

• People whose TB contact (index patient) has TB bacteria resistant to fluoroquinolone antibiotics
• People who have had severe tendon damage caused by fluoroquinolone antibiotics in the past

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