Scholars@Duke

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

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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ICMJE
MLA
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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