PMID: 6375597Jul 1, 1984

Antibiotic trials in intra-abdominal infections. A critical evaluation of study design and outcome reporting

Annals of Surgery
J S SolomkinR L Simmons

Abstract

The introduction of several new antibiotics, including cephalosporins and ureido-penicillins, has been a stimulus for clinical trials with these agents for intra-abdominal infection. Despite marked differences in antibacterial spectra, substantial differences in treatment results have not been documented. We reviewed published trials of antibiotic therapy for intra-abdominal infection to determine factors in study design that might impair identification of clinically important differences between regimens. Sixteen articles were identified that provided sufficient numbers of cases and data for analysis. Eight were prospective comparative trials, the remainder "single-armed" studies. The mortality rate was 3.5%, and the overall success rate was 84% for aminoglycoside plus clindamycin (range 52%-96%), 89% (range 83%-93%) for aminoglycoside plus metronidazole, and 93% (range 61%-95%) for cephalosporin-based regimens. Several defects in study design were identified. (1) Exclusionary criteria employed generally prevented enrollment of seriously ill patients or infections associated with high failure rates: Patients were excluded if even mild renal impairment was present or if antibiotic therapy had been recently administered, thereby...Continue Reading

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Related Concepts

Abdomen
Aminoglycosides
Antibiotics
Bacterial Infections
Dalacin C
Clinical Trials
Polychemotherapy

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