Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-24 @ 5:57 PM
NCT ID:
NCT05664568
Eligibility Criteria:
Inclusion Criteria:
* Consenting adults (≥18 years)
* ≥40 kg
* Smear-positive patients with active tuberculosis, confirmed by sputum smear, TB PCR and/or GeneXpert.
Exclusion Criteria:
* On TB treatment for \>1 day
* Condition affecting ability of an informed consent (i.e. dementia, delirium etc).
* Pregnancy or breast-feeding
* HIV
* Known allergy or sensitivity to any of the study drugs
* Drug-resistant TB (resistance to rifampicin and/or isoniazid)
* Poor general condition or severe infection such that, in the opinion of the investigator at screening, any delay in initiation of definitive TB treatment cannot be tolerated
* TB with concomitant central nervous system and/or cardiac involvement.
* Any condition as determined by physical examination, medical history, laboratory data, or chest x-ray which, in the opinion of the investigator, would interfere with safety or endpoint assessments in the study.
* Use of metformin, probenecid or allopurinol
* Known previous Clostridium difficile infection due to the risk of colitis. (In case no medical records are available, it should be suspected in elderly patients reporting severe gastrointestinal infections in relation to courses of antibiotics)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05664568
Study Brief:
Protocol Section:
NCT05664568