title: Source control review in clinical trials of anti-infective agents in complicated intra-abdominal infections.
abstract: In clinical trials of complicated intra-abdominal infections, assessment of adequacy of the initial surgical approach to the management of the infection is of considerable importance in determining outcome. Antibiotic therapy would not be expected to adequately treat the infection if the surgical procedure was inadequate with respect to source control. Inclusion of such cases in an efficacy analysis of a particular therapeutic antibiotic may confound the results. We analyzed the source control review process used in double-blind clinical trials of antibiotics in complicated intra-abdominal infections identified through systematic review. We searched MEDLINE (PubMed) and ClinicalTrials.gov databases to identify relevant articles reporting results from double-blind clinical trials that used a source control review process. Eight prospective, randomized, double-blind, multicenter, clinical trials of 5 anti-infective agents in complicated intra-abdominal infections used a source control review process. We provide recommendations for an independent, adjudicated source control review process applicable to future clinical trials.
authors: Departments of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH 45267-0558, USA. solomkjs@ucmail.uc.edu
authors: Joseph S
authors: JS
authors: Solomkin
authors: Ross L
authors: RL
authors: Ristagno
authors: Anita F
authors: AF
authors: Das
authors: John B
authors: JB
authors: Cone
authors: Samuel E
authors: SE
authors: Wilson
authors: Ori D
authors: OD
authors: Rotstein
authors: Brian S
authors: BS
authors: Murphy
authors: Kimberley S
authors: KS
authors: Severin
authors: Jon B
authors: JB
authors: Bruss
mesh_terms: D000890:Anti-Infective Agents / Q000008:administration & dosage*; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D032921:Consensus; D006801:Humans; D059413:Intraabdominal Infections / Q000188:drug therapy* / Q000601:surgery*; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards; D012107:Research Design
chemical_list: D000890:Anti-Infective Agents
keywords: adjudication; intra-abdominal infections; review board; source control