Development of New Tuberculosis Drug Regimens-Scientific and Clinical Design Considerations

The Food and Drug Administration is holding a public workshop regarding scientific and clinical trial design considerations for development of new tuberculosis drug regimens. This public workshop is intended to provide information for and gain perspective pertaining to development efforts around new in vitro and in vivo models, new biomarkers and tuberculosis diagnostics, assessing the contribution of 2 or more new components used in combination for to a tuberculosis regimen and clinical trial design challenges.

PredictTB

Predict TB (Using Biomarkers to Predict TB Treatment Duration) will identify the set of criteria needed to reduce TB treatment times. The PredictTB project team will enroll up to 620 patients with drug sensitive pulmonary TB in a clinical trial with five collaborating sites in Cape Town, South Africa and four in Henan Province, China. Over five years, the team will test criteria using data from radiographic lung scans, assays of patient body fluids and analysis of bacterial cultures.

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