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

Publication ,  Journal Article
Johnson, MG; Stout, JE; Benator, DA; Whitworth, WC; Holland, DP
Published in: Int J Tuberc Lung Dis
May 2016
Published version (DOI) Link to item

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.

Duke Scholars

Jason Eric Stout
Author Jason Eric Stout Medicine, Infectious Diseases
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Published In

Int J Tuberc Lung Dis

DOI

10.5588/ijtld.15.0570

EISSN

1815-7920

Publication Date

May 2016

Volume

20

Issue

5

Start / End Page

600 / 604

Location

France

Related Subject Headings

  • Tuberculosis
  • Treatment Outcome
  • Time Factors
  • Sample Size
  • Reproducibility of Results
  • Predictive Value of Tests
  • Mycobacterium tuberculosis
  • Microbiology
  • Humans
  • Endpoint Determination
 

Citation

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Johnson, M. G., Stout, J. E., Benator, D. A., Whitworth, W. C., & Holland, D. P. (2016). Medium matters: modeling the impact of solid medium performance on tuberculosis trial sample size requirements. Int J Tuberc Lung Dis, 20(5), 600–604. https://doi.org/10.5588/ijtld.15.0570
Johnson, M. G., J. E. Stout, D. A. Benator, W. C. Whitworth, and D. P. Holland. “Medium matters: modeling the impact of solid medium performance on tuberculosis trial sample size requirements.” Int J Tuberc Lung Dis 20, no. 5 (May 2016): 600–604. https://doi.org/10.5588/ijtld.15.0570.
Johnson MG, Stout JE, Benator DA, Whitworth WC, Holland DP. Medium matters: modeling the impact of solid medium performance on tuberculosis trial sample size requirements. Int J Tuberc Lung Dis. 2016 May;20(5):600–4.
Johnson, M. G., et al. “Medium matters: modeling the impact of solid medium performance on tuberculosis trial sample size requirements.” Int J Tuberc Lung Dis, vol. 20, no. 5, May 2016, pp. 600–04. Pubmed, doi:10.5588/ijtld.15.0570.
Johnson MG, Stout JE, Benator DA, Whitworth WC, Holland DP. Medium matters: modeling the impact of solid medium performance on tuberculosis trial sample size requirements. Int J Tuberc Lung Dis. 2016 May;20(5):600–604.

Published In

Int J Tuberc Lung Dis

DOI

10.5588/ijtld.15.0570

EISSN

1815-7920

Publication Date

May 2016

Volume

20

Issue

5

Start / End Page

600 / 604

Location

France

Related Subject Headings

  • Tuberculosis
  • Treatment Outcome
  • Time Factors
  • Sample Size
  • Reproducibility of Results
  • Predictive Value of Tests
  • Mycobacterium tuberculosis
  • Microbiology
  • Humans
  • Endpoint Determination