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

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...

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Bibliographic Details
Published in:The international journal of tuberculosis and lung disease 2016-05, Vol.20 (5), p.600-604
Main Authors: Johnson, M. G., Stout, J. E., Benator, D. A., Whitworth, W. C., Holland, D. P.
Format: Article
Language:English
Subjects:
Antitubercular Agents - therapeutic use
Bacteriological Techniques
Clinical Trials
Clinical Trials, Phase II as Topic - methods
Controlled Clinical Trials as Topic - methods
Culture Media
Endpoint Determination
Humans
Mathematical Modeling
Microbiology
Mycobacterium
Mycobacterium Tuberculosis
Mycobacterium tuberculosis - drug effects
Mycobacterium tuberculosis - growth & development
Mycobacterium tuberculosis - isolation & purification
Predictive Value of Tests
Reproducibility of Results
Sample Size
Time Factors
Treatment Outcome
Tuberculosis - diagnosis
Tuberculosis - drug therapy
Tuberculosis - microbiology
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Summary: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.
ISSN:1027-3719
1815-7920
DOI:10.5588/ijtld.15.0570