M G Johnson1, J E Stout1, D A Benator2, W C Whitworth3, D P Holland4. 1. Division of Infectious Diseases and International Health, Duke University Medical Center, Durham, North Carolina, USA. 2. Infectious Diseases Section, Veterans Affairs Medical Center and the George Washington University Medical Center, Washington DC, USA. 3. Clinical Research Branch, Division of Tuberculosis Elimination, Centers for Disease Control and Prevention, Atlanta, USA. 4. Division of Infectious Diseases and International Health, Duke University Medical Center, Durham, North Carolina, USA; Division of Infectious Diseases, Emory University, Atlanta, Georgia, USA.
Abstract
SETTING: Two-month solid medium culture conversion is a commonly used, if suboptimal, endpoint for phase 2 anti-tuberculosis treatment trials. OBJECTIVE AND DESIGN: To model the effect of the performance characteristics (sensitivity and contamination rate) of solid medium on required sample size for a two-arm clinical trial with 85% true (gold standard) culture conversion in the control and 95% in the experimental arm. RESULTS: Increasing sensitivity and decreasing contamination reduced the sample size from 239 subjects/arm (60% sensitivity, 30% contamination) to 138 subjects/arm (95% sensitivity, 1% contamination). CONCLUSION: Optimizing solid medium has significant potential to reduce sample size and increase the efficiency of tuberculosis clinical trials.
SETTING: Two-month solid medium culture conversion is a commonly used, if suboptimal, endpoint for phase 2 anti-tuberculosis treatment trials. OBJECTIVE AND DESIGN: To model the effect of the performance characteristics (sensitivity and contamination rate) of solid medium on required sample size for a two-arm clinical trial with 85% true (gold standard) culture conversion in the control and 95% in the experimental arm. RESULTS: Increasing sensitivity and decreasing contamination reduced the sample size from 239 subjects/arm (60% sensitivity, 30% contamination) to 138 subjects/arm (95% sensitivity, 1% contamination). CONCLUSION: Optimizing solid medium has significant potential to reduce sample size and increase the efficiency of tuberculosis clinical trials.
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