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 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT05555303
Eligibility Criteria:
Inclusion Criteria:
* Enrolled in the Master SHORRT study
* Able and willing to provide written informed consent for the present substudy "Stake"
Exclusion Criteria:
* Any audiometry abnormality (grade 1 or higher) on baseline audiometry
* History of kidney disease or baseline creatinine clearance below or equal to 60ml/min
* Pregnant or breastfeeding women
* History of previous injectable based tuberculosis treatment (including with streptomycin)
* \< 18 years and \> 65 years old
* Patient on NSAID or on diuretics
Master ShORRT study
Inclusion criteria:
* Is willing and able to give informed consent to be enrolled in the research project and for follow-up
* Has bacteriologically or molecularly confirmed TB with evidence of resistance to at least rifampicin
Exclusion criteria:
* Is unable to take oral medication;
* Must take any medications contraindicated with the medicines in the MDR/RR-TB regimen;
* Has a known allergy to any of the drugs in the MDR/RR-TB regimen;
* Has a QTcF interval of ≥ 500 msec; at baseline that does not correct with medical management.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
64 Years
Study:
NCT05555303
Study Brief:
Protocol Section:
NCT05555303