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

Journal Article (Journal Article)

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.

Full Text

Duke Authors

Cited Authors

  • Johnson, MG; Stout, JE; Benator, DA; Whitworth, WC; Holland, DP

Published Date

  • May 2016

Published In

Volume / Issue

  • 20 / 5

Start / End Page

  • 600 - 604

PubMed ID

  • 27084812

Pubmed Central ID

  • PMC4960979

Electronic International Standard Serial Number (EISSN)

  • 1815-7920

Digital Object Identifier (DOI)

  • 10.5588/ijtld.15.0570


  • eng

Conference Location

  • France