Intensified tuberculosis treatment to reduce the mortality of HIV-infected and uninfected patients with tuberculosis meningitis (INTENSE-TBM): study protocol for a phase III randomized controlled trial
DiscussionThe INTENSE-TBM trial represents a key opportunity to enhance TBM treatment with widely available existing drugs notably in high-incidence settings of both TB and HIV. The trial design is pragmatic and the results will permit early and effective applications in TBM patient care, in both HIV and TB high-incidence countries.Trial registrationClinicalTrials.gov NCT04145258. Registered on October 30, 2019. (Source: Trials)
Source: Trials - November 8, 2022 Category: Research Source Type: clinical trials

Evaluation of cultural competency in a South African cluster randomised controlled trial: lessons learned for trial reporting standards
ConclusionsComprehensive evaluation of the trial ’s cultural competency required scrutiny of both published manuscripts and source and procedural data, suggesting that there is a gap in current trial reporting standards with respect to cultural competence.Trial registrationPACTR201610001825403. Registered on 17 October 2016. (Source: Trials)
Source: Trials - October 29, 2022 Category: Research Source Type: clinical trials

Sequencing Mycobacteria and Algorithm-determined Resistant Tuberculosis Treatment (SMARTT): a study protocol for a phase IV pragmatic randomized controlled patient management strategy trial
DiscussionThis trial will provide important real-life evidence regarding the feasibility, safety, cost, and effectiveness of a WGS-guided automated treatment recommendation strategy for individualized treatment of RR-TB. Given the pragmatic nature, the trial will assist policymakers in the decision-making regarding the integration of next-generation sequencing technologies into routine RR-TB care in high TB burden settings.Trial registrationClinicalTrials.gov NCT05017324. Registered on August 23, 2021. (Source: Trials)
Source: Trials - October 8, 2022 Category: Research Source Type: clinical trials

Pragmatic Use of Next-generation Sequencing to Improve Management of Drug-resistant Tuberculosis
Conditions:   Drug-resistant Tuberculosis;   HIV Coinfection;   Cost-Benefit Analysis Intervention:   Diagnostic Test: Targeted next-generation sequencing Sponsors:   University of California, San Francisco;   University of Stellenbosch;   National Health Laboratory Service (NHLS), South Africa;   National Institute for Communicable Diseases, South Africa;   Translational Genomics Research Institute;   National Institute of Allergy and Infectiou s Diseases (NIAID);   University Hospital Heidelberg Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - September 23, 2022 Category: Research Source Type: clinical trials

Pragmatic Use of Next-generation Sequencing for Management of Drug-resistant Tuberculosis
Conditions:   Drug-resistant Tuberculosis;   HIV Coinfection;   Cost-Benefit Analysis Intervention:   Diagnostic Test: Targeted next-generation sequencing Sponsors:   University of California, San Francisco;   University of Stellenbosch;   National Health Laboratory Service (NHLS), South Africa;   National Institute for Communicable Diseases, South Africa;   National Institute of Allergy and Infectious Diseases (NIAID);   Find;   Translational Ge nomics Research Institute;   University Hospital Heidelberg Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - September 23, 2022 Category: Research Source Type: clinical trials