Phase 2 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 are able to give written consent to participate, including consent for HIV testing, before any trial procedures begin.
• People aged between 18 and 65 years old (inclusive).
• People who weigh between 40 and 90 kg (measured in light clothing without shoes).
• People who have been newly diagnosed with pulmonary (lung) tuberculosis (TB) that has not been treated before, and where lab tests confirm the TB bacteria are sensitive to the standard antibiotics rifampicin and isoniazid. People with a past history of TB may also be considered if their previous treatment was completed, their TB appeared to be cured, there is no ongoing sign of TB bacteria, and their last dose of TB treatment was more than 3 months ago.
• People who have had a chest X-ray taken within the last 2 weeks that shows signs the trial doctor considers consistent with TB.
• People whose sputum (mucus coughed up from the lungs) tests positive for TB bacteria at a certain level on at least one standard lab test.
• People who understand that certain foods may interact with the study drugs and who are willing to avoid those foods for the duration of the study.
• People who are not able to become pregnant, or who are willing to use effective contraception methods as specified by the trial, for the required period. This includes specific requirements depending on the stage of the trial and the participant's situation (confirm with trial site for full details).

Who may not be able to join:

• People whose situation raises concerns about whether they are freely and independently able to consent — for example, people in detention or people with a mental disability affecting their decision-making.
• People in very poor general health where starting treatment cannot be delayed, or where the trial doctor considers survival beyond four months unlikely.
• People whose personal circumstances make it unlikely they would be able to complete all follow-up visits during the study, in the trial doctor's opinion.
• People who are pregnant, breastfeeding, or planning to become pregnant during the study period.
• People who are living with HIV and have a CD4 cell count below 220 cells/mm³. People with HIV and a CD4 count above 220 cells/mm³ may be considered, but only under specific conditions relating to their HIV treatment — confirm full details with the trial site.
• People who are known to have an intolerance or allergy to any of the study drugs, or who have a condition that would make taking the study drugs or standard TB treatment unsafe.
• People who have certain serious health conditions that the trial doctor believes could affect how well the treatment works, how safely the person can participate, or their overall survival. These include, but are not limited to: nerve damage or significant mental health conditions such as depression or schizophrenia; TB that has spread significantly beyond the lungs; serious lung conditions other than TB; uncontrolled diabetes or diabetes managed with certain medications (metformin or sulfonylureas); heart conditions such as heart attack, heart failure, or irregular heartbeat; uncontrolled high blood pressure; a personal or family history of a heart rhythm condition called Long QT syndrome or unexplained sudden death in the family; significant alcohol, opiate, or drug misuse — including any use of methamphetamine; a history of a condition affecting the optic nerve (optic neuropathy); or the skin condition vitiligo.
• People whose blood test results at the screening stage show abnormal liver function, abnormal kidney function (with specific thresholds depending on the trial stage), protein in the urine above a certain level, low haemoglobin (anaemia), low platelet count, or persistently low potassium levels — confirm specific values with the trial site.
• People whose heart tracing (ECG) at screening shows certain abnormalities, including a prolonged QTc interval, certain electrical conduction delays, or other changes considered clinically relevant by the trial doctor.
• People who have taken another experimental drug within the 2 months before joining, or who are already participating in another clinical intervention trial.
• People who have taken any anti-TB medication within the 3 months before screening.
• People who are unable or unwilling to follow the trial's rules about restricted medications (confirm the full list of restricted medications with the trial site).

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