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 @ 2:08 PM
Ignite Modification Date:
2025-12-24 @ 2:08 PM
NCT ID:
NCT04721795
Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria:
1. Newly diagnosed, uncomplicated, drug-susceptible pulmonary TB
2. Sputum Smear, culture or GenXpert result positive for pulmonary TB
3. Ability to provide written, informed consent prior to trial initiation
4. Male or and non pregnant female participants between 18 and 65 years of age
5. Body mass index 16.0 and 32.0 kg/m2
6. Ability to produce an adequate volume of sputum (approximately 10 -15mL or more estimated overnight production).
Exclusion Criteria:
Exclusion Criteria:
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1. Participants known or suspected of having any form of drug resistance TB.
2. Patients co infected with HIV
3. Those with poor general condition where no delay in treatment can be tolerated
4. Evidence of clinically significant metabolic or co morbid medical conditions ; malignancy; or other diseases like history of or current cardiovascular disorder such as heart failure, coronary heart disease, arrhythmia.
5. Known or family history of bleeding disorders.
6. Any renal impairment characterized by serum creatinine clearance of 1.5 x upper limit of normal of the clinical laboratory reference range at screening.
7. Myositis and or Creatinine phosphokinase three times upper limit of normal
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04721795
Study Brief:
Protocol Section:
NCT04721795