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Published on: September 20, 2019

Clinical trial design for mild-to-moderate community-acquired pneumonia--an industry perspective

Roger M Echols1, Glenn S Tillotson, James X Song

  • 1Replidyne, Inc., Louisville, Colorado, USA. rechols@id3c.com

Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America
|November 18, 2008
PubMed

Insights

Establishing the benefit of antibiotic treatment for community-acquired pneumonia is challenging. This study proposes noninferiority margins for future trials based on historical data and a levofloxacin superiority study.

Area of Science:

  • Clinical Medicine
  • Infectious Diseases
  • Clinical Trials

Background:

  • Noninferiority trials require established benefit of active control over no treatment.
  • Placebo-controlled trials for antibiotic benefits in community-acquired pneumonia are lacking.
  • Historical data confirm mortality reduction from antimicrobials, but mortality is unsuitable for mild-to-moderate ambulatory pneumonia trials.

Purpose of the Study:

  • To propose appropriate noninferiority margins for future clinical trials in mild-to-moderate community-acquired pneumonia.
  • To justify these margins using historical data and a contemporary superiority trial.

Main Methods:

  • Review of historical clinical data on spontaneous recovery in Streptococcus pneumoniae pneumonia.
  • Analysis of a contemporary clinical trial comparing levofloxacin to ceftriaxone/cefuroxime for community-acquired pneumonia.
  • Justification of noninferiority margins based on established treatment efficacy.

Main Results:

  • Historical data and a levofloxacin superiority trial provide a basis for setting noninferiority margins.
  • A 10% noninferiority margin is proposed for the per-protocol population.
  • A 15% noninferiority margin is proposed for the microbiologically evaluable population.

Conclusions:

  • Noninferiority margins for community-acquired pneumonia trials can be justified.
  • These margins are essential for designing future clinical trials evaluating antibiotic treatments.
  • The proposed margins facilitate the assessment of new therapies for mild-to-moderate community-acquired pneumonia.

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