Medium matters: modeling the impact of solid medium performance on tuberculosis trial sample size requirements

作者：Johnson M G; Stout J E^*; Benator D A; Whitworth W C; Holland D P

来源：International Journal of Tuberculosis and Lung Disease, 2016, 20(5): 600-604.

DOI：10.5588/ijtld.15.0570

• Mycobacterium tuberculosis
• clinical trials
• mathematical modeling
• microbiology

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.

• 出版日期2016-5