NWCS 445: Novel Biomarkers to Shorten TB Treatment NWCS 445: Novel Biomarkers to Shorten TB Treatment: A Substudy of S31/A5349
Study Location:
India
Topic:
Tuberculosis and HIV
IRB#:
IRB00144879
Enrollment:
Closed
Trial Period:
Ongoing
Objectives:
Primary:
- To develop a highly predictive algorithm that identifies TB patients who will be cured by treatment with shortened-duration regimens in a model that includes measured host clinical characteristics, pharmacokinetic data, and key bacterial measures.
Secondary:
- To test and refine measures of initial bacterial load as predictors of successful four- and six-month TB treatments
- To test and refine measures of change in bacterial load during treatment as predictors of successful four- and six-month TB treatments
- To investigate the contribution of M. tuberculosis sub-breakpoint minimum inhibitory concentrations as predictors of successful four- and six-month TB treatments
- To identify simplified bacterial markers with the potential to be developed into a predictive test to identify TB patients who will be cured by treatment with shortened-duration regimens
Partncipants enrolled in “Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: a randomized, open-label, controlled phase 3 clinical trial” (CDC TB Trials Consortium Study 31/AIDS Clinical Trials Group Study A5349 [S31/A5349]; NCT02410772)