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 @ 1:40 PM
Ignite Modification Date:
2025-12-24 @ 1:40 PM
NCT ID:
NCT05007795
Eligibility Criteria:
Inclusion Criteria:
Subjects are required to meet ALL of the following inclusion criteria to participate:
* Newly diagnosed culture and/or Xpert/MTB Ultra positive pulmonary TB
* Rifampicin resistance detected using GeneXpert
* Provide written informed consent prior to all trial-related procedures
* Male or female aged 18 years and older.
* Patients on TB treatment for less than or equal to 7 days.
* Patients receiving both the shorter and longer MDR-TB regimen will be eligible.
Exclusion Criteria:
Subjects will be excluded from participation if they meet ANY of the following criteria:
* A subject who in the opinion of the investigator is unlikely to cope with regular visits to the trial site either because of travel constraints, or drug or alcohol abuse, or other reason.
* Currently on MDR-TB treatment and completed 7 days of treatment.
* Any participant with a clinically significant pre-existing medical condition that, in the opinion of the investigator, may be significantly worsened by the patient's participation in the study
* Any subject with a Karnofsky score \< 50.
* Having participated in other clinical studies within 8 weeks prior to trial start where investigational agents were used that may potentially impact current trial outcome.
* Participant who is pregnant, breast-feeding (and not willing to stop), or planning to conceive a child within 6 months of cessation of treatment.
* Any pre-existing laboratory abnormality, which in the opinion of the investigator will place the participant at risk (see detailed protocol for grade of abnormality).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05007795
Study Brief:
Protocol Section:
NCT05007795