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Medium matters: modeling the impact of solid medium performance on tuberculosis trial sample size requirements
M G Johnson1, J E Stout1, D A Benator2
1Division of Infectious Diseases and International Health, Duke University Medical Center, Durham, North Carolina, USA.
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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