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:

• A parent or guardian is willing and able to give written permission for the child to take part, and the child is also willing to agree to participate where required by the reviewing ethics board.
• The child is under 10 years of age at the time of joining.
• The child weighs at least 3 kilograms at the time of joining.
• The child has been diagnosed with tuberculosis (TB) affecting the lungs (including fluid around the lungs) and/or lymph nodes, with or without lab confirmation, and the treating doctor has decided to treat with the standard first-line TB medicines.
• The child's HIV status is already known, or HIV testing is underway according to the required testing process.
• Recent blood test results (done within 14 days of joining) show that liver enzymes, bilirubin, potassium, haemoglobin, platelet count, and kidney function are all within acceptable ranges.
• For children who are living with HIV and already on HIV treatment: the treating doctor has placed them on, or is able to switch them to, a treatment regimen containing dolutegravir at or before joining.
• For children living with HIV who are not yet on HIV treatment: the treating doctor plans to start a dolutegravir-based regimen by week 4 of the study.
• For participants who have started their menstrual periods or who are sexually active: a pregnancy test done within 7 days of joining must come back negative.
• For participants who are sexually active in a way that could lead to pregnancy: an agreement to use at least one non-hormonal form of contraception (such as condoms, a diaphragm or cervical cap with spermicide if available, or a non-hormonal IUD/IUS) or to abstain from sex during treatment and for 30 days after finishing the study medicines.
• The child is expected to remain within the study site's area for the full follow-up period, or the parent/guardian agrees to follow-up outside that area if needed, as determined by the site investigator.

Who may not be able to join:

• Children who are suspected or confirmed to have TB affecting the brain or nervous system, bones, joints, the sac around the heart, the digestive tract, the kidneys, or TB that has spread throughout the body (miliary TB).
• Babies who were born before 37 weeks of pregnancy and are under 3 months old at the time of joining.
• Children who have a known reason they cannot take any of the study medicines, including a known allergy or intolerance to any study drug, use of medications that are not allowed within 3 days before or planned within 6 months of joining, inability to take medicines by mouth, or a known history of a heart rhythm condition called prolonged QT syndrome (not caused by low electrolyte levels).
• Children who have already received more than 10 days of TB treatment in the 6 months before starting the study medicines.
• Children whose TB is known or suspected to be resistant to any of the key TB medicines used in the study (isoniazid, rifampin, pyrazinamide, ethambutol, or fluoroquinolones).
• Children who are known to have been in close contact with an adult who had drug-resistant TB, including resistance to isoniazid, rifampin, pyrazinamide, ethambutol, or fluoroquinolones.
• Children who have another significant medical condition that, in the site investigator's opinion, would make participation unsafe, affect the study results, or interfere with the study's goals.
• Children who have previously been enrolled in this same study.
• Children whose TB bacteria (if grown in a lab or identified through approved testing) are found to be resistant to any of the key study medicines after joining (confirm with trial site).
• Children diagnosed with TB based on symptoms who are later found to have a different condition explaining their symptoms, and whose TB treatment is stopped before it is completed.

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