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Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses
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Source control review in clinical trials of anti-infective agents in complicated intra-abdominal infections

Joseph S Solomkin1, Ross L Ristagno, Anita F Das

  • 1Departments of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH 45267-0558, USA. solomkjs@ucmail.uc.edu

Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America
|March 7, 2013
PubMed

Insights

Adequate surgical source control is crucial for treating complicated intra-abdominal infections. Inadequate surgery can confound antibiotic efficacy trials, necessitating a standardized review process.

Area of Science:

  • Infectious Diseases
  • Surgical Infections
  • Clinical Trial Methodology

Background:

  • Effective management of complicated intra-abdominal infections (cIAI) relies on both surgical source control and antibiotic therapy.
  • Inadequate surgical intervention can compromise antibiotic efficacy, potentially confounding clinical trial results.
  • Standardized assessment of surgical source control is vital for accurate interpretation of antibiotic trial outcomes.

Purpose of the Study:

  • To analyze the source control review process in existing double-blind clinical trials for cIAI.
  • To identify best practices and propose recommendations for an independent, adjudicated source control review process in future trials.

Main Methods:

  • Systematic review of double-blind clinical trials for cIAI.
  • Searches conducted in MEDLINE (PubMed) and ClinicalTrials.gov databases.
  • Analysis focused on trials incorporating a source control review process.

Main Results:

  • Eight prospective, randomized, double-blind, multicenter clinical trials met the inclusion criteria.
  • These trials evaluated 5 different anti-infective agents for cIAI.
  • A source control review process was utilized in all identified trials.

Conclusions:

  • The adequacy of initial surgical source control is a critical factor in determining treatment outcomes for cIAI.
  • A robust and independent source control review process is essential for the integrity of antibiotic clinical trials.
  • Recommendations are provided for implementing an adjudicated source control review process in future cIAI trials.
Keywords:
adjudicationintra-abdominal infectionsreview boardsource control

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