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:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT05575518
Eligibility Criteria:
Inclusion Criteria:
* Each patient must meet all the following inclusion criteria prior to enrolment into the trial:
1. The patient has given fully informed, signed written or witnessed oral informed consent for study participation prior to all trial-related procedures, including HIV testing if HIV status is not known.
2. The patient has a diagnosis of pulmonary TB established by Xpert MTB/RIF® result which confirms "low" "medium" or "high" level detection of M tuberculosis and does not detect rifampicin resistance.
1. If the patient has been referred from a clinic at which the pre-screening clinical diagnostic test for TB was an Xpert MTB/RIF® assay done at the trial laboratory, and the full read-out of that result is available, the test does not need to repeated to confirm eligibility.
2. If the patient has been referred from a clinic at which the pre-screening clinical diagnostic test for TB was an Xpert MTB/RIF® assay done at a non-trial laboratory, but the full read-out of that result is available, the test does not need to repeated to confirm eligibility.
3. If the patient has been referred to the study from a clinic from which the full pre-screening clinical diagnostic Xpert MTB/RIF® test result is unavailable, a repeat Xpert MTB/RIF® assay should be performed by the study laboratory to confirm eligibility before recruitment.
3. The patient should be aged ≥ 18 years on the day of providing informed consent.
4. The patient has a body weight in light clothing and without shoes of at least 35kg.
5. Female patients of child-bearing potential must have a negative urine or serum pregnancy test ≤ 7 days prior to screening, and consent to practice an effective method of contraception until completion of therapy.
6. The patient must have a verifiable residence location and telephone number that is accessible if necessary for contact during follow-up.
Exclusion Criteria:
* Patients for whom one of the following criteria is met will be excluded from the trial:
1. There is concern about any circumstances that raise concern about free, informed consent to study participation.
2. The patient's pre-screening or screening Xpert MTB/RIF® assay result is "negative","trace", or "very low" positive.
3. At least one M tuberculosis isolate, either cultured or detected through molecular assays from sputum obtained from the patient prior to treatment initiation is found to be resistant to one or more of: rifampicin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones (late exclusion).
4. The patient is in poor general condition where delay in treatment cannot be tolerated, or death within three months is likely, as assessed by the investigator.
5. The patient had a nose/throat swab which was positive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2), on Polymerase Chain Reaction (PCR) or a rapid diagnostic test ≤ 14 days preceding study recruitment.
6. The patient is pregnant or breast-feeding (female patients only).
7. The patient is unable to take oral medications.
8. The patient has received any investigational drug in the past three months.
9. The patient has received more than five days of treatment directed against active tuberculosis ≤ 6 months preceding initiation of study drugs.
10. The patient has known intolerance to any of the study drugs, or conditions for which they are contra-indicated.
11. The patient is unwilling, or unable to adhere to requirements regarding restricted use of other medications during the study. Restricted medications will include medications which prolong the QTc interval, and CYP450 inhibitors or inducers.
12. The patient is due to initiate, or requires continuation of, non-efavirenz, non-dolutegravir-based anti-retroviral therapy for HIV infection.
13. The patient has decompensated liver disease and/or aminotransaminases \>3x upper limit of normal (ULN), serum total bilirubin level \>1.5x ULN or serum/plasma creatinine level \>x2 ULN.
14. The patient has a baseline QTc interval of \>450ms.
15. The patient is being, or about to be, treated for malaria.
16. The patient has other medical conditions that, in the investigator's judgement, make study participation not in the individual's best interest.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05575518
Study Brief:
Protocol Section:
NCT05575518