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:

• The person has agreed to take part and signed a consent form before any trial-related procedures begin.
• The person has been diagnosed with pulmonary tuberculosis (TB that affects the lungs) according to local diagnostic guidelines.
• The person is 18 years of age or older at the time of signing the consent form.
• The person has no known history of allergic reactions or bad reactions to the antibiotic rifampicin.
• Women who could become pregnant must have a negative blood pregnancy test, agree to use two forms of effective birth control (at least one must be a barrier method, such as a condom) throughout the trial, and must not be breastfeeding. Women who have not had a period for at least 12 months, or who have had certain surgical procedures such as removal of the ovaries, a hysterectomy, or tubal ligation at least 12 months before joining, are not required to meet this condition.
• The person is expected to be able to follow the trial schedule, as judged by the trial doctor.

Who may not be able to join:

• The person's TB has already been assessed as needing high-dose rifampicin as part of standard local care.
• The person started their current TB treatment more than 4 weeks ago.
• The person has TB that has spread to the membranes surrounding the brain (TB meningitis).
• The person is currently in a coma.
• There are concerns that the person may not be giving consent freely and without pressure (for example, if the person is incarcerated or has an intellectual disability).
• The person is not able to personally give their own consent.
• The person is in poor general health, has other serious illnesses where a delay in treatment could not be tolerated, or is likely to pass away within three months — or has other treatments underway that could interfere with the trial.
• The person is pregnant or breastfeeding.
• The person's TB is caused by a strain of the bacteria that is resistant to rifampicin.
• The person has a known allergy or intolerance to the rifamycin family of antibiotics.
• The person has a current problem with alcohol, drug, or amphetamine use that, in the trial doctor's opinion, could affect their safety or ability to cooperate with the trial.
• The person has a known allergy, intolerance, or medical condition that makes it unsafe to take rifampicin or other standard TB medications.
• The person has taken part in another clinical drug trial within the past month, or is planning to join another clinical intervention trial in the next 6 months.
• Blood test results at screening showed one or more of the following: liver enzyme levels (AST and/or ALT) more than 3 times the upper limit of normal; bilirubin levels more than 2.5 times the upper limit of normal; or kidney function (creatinine clearance) below 30 mL/min.
• The person has a history of severe or life-threatening liver disease caused by medication.
• The person has a long-term liver or kidney condition.
• The person has jaundice (yellowing of the skin or eyes).
• The person completed a previous course of TB treatment within the last 3 months.

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