Tuberculosis, Multidrug-Resistant Clinical Trial
— InDEXOfficial title:
The Individualized M(X) Drug-resistant TB Treatment Strategy Study A Strategy to Improve Treatment Outcomes in Patients With Drug-resistant TB
Verified date | August 2023 |
Source | Centre for the AIDS Programme of Research in South Africa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 African National Tuberculosis guidelines.
Status | Terminated |
Enrollment | 205 |
Est. completion date | December 19, 2022 |
Est. primary completion date | December 19, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
South Africa | King Dinuzulu Hospital | Durban | Kwa-Zulu Natal |
Lead Sponsor | Collaborator |
---|---|
Centre for the AIDS Programme of Research in South Africa |
South Africa,
Musser JM. Antimicrobial agent resistance in mycobacteria: molecular genetic insights. Clin Microbiol Rev. 1995 Oct;8(4):496-514. doi: 10.1128/CMR.8.4.496. — View Citation
Outhred AC, Jelfs P, Suliman B, Hill-Cawthorne GA, Crawford AB, Marais BJ, Sintchenko V. Added value of whole-genome sequencing for management of highly drug-resistant TB. J Antimicrob Chemother. 2015 Apr;70(4):1198-202. doi: 10.1093/jac/dku508. Epub 2014 Dec 9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Culture negative survival rate | To determine if a gene-derived individualized treatment approach in patients with drug-resistant TB will improve culture negative survival rates at 6 months post treatment initiation | 24 months | |
Primary | Culture negative survival rate | To determine if a gene-derived individualized treatment approach in patients with drug-resistant TB will improve culture negative survival rates at 6 months post treatment initiation | 30 months | |
Secondary | Tuberculosis treatment outcomes | Treatment outcomes are based on treatment success (cure rates and completion of treatment) or mortality or retention in care or time to culture conversion | 30 months | |
Secondary | Rates of adverse events | Rates of adverse events will be compared between arms | 30 months | |
Secondary | Characterization of multi drug-resistant tuberculosis strains | The minimum inhibitory concentrations of Mtb isolates will be correlated with the genotypic mutations detected and the evolution of drug resistance will be monitored by comparing serial isolates from patients | 30 months | |
Secondary | Drug Concentration | To determine the drug concentrations and long-term drug exposures to DR-TB drug regimens in DBS and hair samples respectively | 30 months | |
Secondary | Measure of adherence | To compare adherence to DR-TB drugs using drug concentrations in DBS samples, hair samples, pill count data and participant self-report | 30 months | |
Secondary | Evolution of HIV drug resistance | To assess the evolution of HIV drug resistance in patients receiving Bedaquiline and ART for HIV/MDR-TB treatment | 30 months | |
Secondary | Improved assessment and management of DR-TB | Development of an optimized method for extraction of MTB DNA directly from sputum samples for WGS, compare resistance mutations detected by WGS to current Xpert and LPA; to design a clinical decision-making algorithm for assessment and management of detected resistance mutations | 30 months |
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