Status:
TERMINATED
The Individualized M(X) Drug-resistant TB Treatment Strategy Study
Lead Sponsor:
Centre for the AIDS Programme of Research in South Africa
Conditions:
Tuberculosis, Multidrug-Resistant
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a randomized controlled clinical trial comparing treatment success of a gene-derived individualized drug-resistant Tuberculosis regimen to a standard Tuberculosis regimen based on South Africa...
Detailed Description
When drug resistance is detected by molecular methods such as the Xpert MTB/RIF assay, second-line Multi Drug-Resistant (MDR) Tuberculosis treatment is started in the complete absence of detailed resi...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Adults ≥ 18 years of age
- Pulmonary Tuberculosis
- Microbiological confirmation \[e.g. GeneXpert Mycobacterium Tuberculosis (MTB) detected and Rifampicin (RIF) resistant and / Line Probe Assay (LPA)\] of Multi drug-resistant tuberculosis (MDR-TB) / Pre-Extremely drug-resistant tuberculosis (Pre-XDR-TB) / Extremely drug-resistant tuberculosis (XDR-TB)
- Capacity for providing informed consent
- HIV status - HIV infected and uninfected patients are allowed in the study:
- Patients already on antiretroviral treatment (ART) will be allowed in the study. The antiretroviral treatment regimen will be evaluated for any contraindications to the drugs used.
- HIV infected patients at any CD4 count irrespective of antiretroviral treatment commencement and duration will be included in the study
- Exclusion Criteria:
- Persons suffering from any serious acute condition.
- Any other chronic or clinically significant medical condition that in the opinion of the attending clinician would render the patient unsuitable for participation in the study.
Exclusion
Key Trial Info
Start Date :
June 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2022
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT03237182
Start Date
June 14 2017
End Date
December 19 2022
Last Update
September 1 2023
Active Locations (1)
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1
King Dinuzulu Hospital
Durban, KwaZulu-Natal, South Africa