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 who have a latent TB infection (meaning they carry the TB bacteria but do not have active TB disease), shown by a positive skin test or blood test, and who are at higher risk of developing active TB due to at least one of the following reasons:
• People who have spent more than 4 hours per week with someone who has been confirmed to have TB, within the past 2 years.
• People whose TB skin test or blood test changed from negative to positive within the past 2 years, suggesting a recent infection.
• People who are living with HIV and have a CD4 immune cell count above 100 cells/mm³ (confirm with trial site).
• People whose chest X-ray shows at least 2 cm² of lung scarring and who have never been treated for TB or latent TB.
• People who moved to a country with low to moderate TB rates within the past 3 years, whose chest X-ray shows abnormal results, and who do not have active TB.
• People who moved to a country with low to moderate TB rates within the past 3 years from a country where TB rates are higher than 150 per 100,000 people, and who have a positive blood test or a sufficiently strong positive skin test result.
• People seeking refugee or asylum status who moved to a country with low to moderate TB rates within the past 3 years from a country where TB rates are higher than 75 per 100,000 people, and who have a positive blood test or a sufficiently strong positive skin test result.
• People with certain medical conditions that raise the risk of developing TB, such as end-stage kidney disease.
• People currently taking long-term steroid medications or other medicines that weaken the immune system.
• People who are planning to start a type of medication called a TNF-alpha inhibitor (a medicine used for conditions like rheumatoid arthritis).
• People who are planning to have an organ or bone marrow transplant.
• People who are willing and able to give signed consent to participate (or, for children, a parent or guardian gives permission and the child agrees).
• Pregnant women in their second or third trimester (14 weeks or more), under specific conditions depending on the stage of the trial.
• Children under 12 years old, under specific conditions depending on the stage of the trial (confirm with trial site).

Who may not be able to join:

• People who do not have a documented positive TB skin test or blood test result.
• People who are currently breastfeeding.
• People who are pregnant in their first trimester (less than 14 weeks) or who plan to become pregnant within 120 days of joining the trial.
• Women who are not pregnant but could become pregnant and are not willing to use an adequate form of contraception (such as barrier methods or a non-hormonal intrauterine device) or avoid activities that could lead to pregnancy.
• People who currently have active TB, are suspected of having active TB, or where active TB cannot be reasonably ruled out by the treating doctor.
• People whose TB came from a source where the TB bacteria was resistant to a type of antibiotic called a rifamycin.
• People who have taken certain TB medications (rifamycins or isoniazid) for more than a specified period within the past 2 years (confirm with trial site for exact details).
• People who have a documented history of completing a full course of treatment for active TB or latent TB, and who are not living with HIV.
• People with a known allergy or bad reaction to rifamycin-type medications.
• People whose liver enzyme levels (measured by a blood test) are more than 5 times the normal upper limit, if liver tests were done during screening.
• People who are taking other medications that are known to be unsafe to use alongside the study drugs.
• Participants aged 12 years or older who weigh less than 25 kg, or participants under 12 years who weigh less than 3 kg.

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