drugset / Trial / NCT00613769

Orally Administered Trimethoprim-sulfamethoxazole and Metronidazole as Prophylaxis of Infection Following Elective Colorectal Surgery

NCT00613769

Phase 4 Completed 1073 enrolled Halmstad County Hospital
RandomizedParallel-groupTriple-blindPrevention

Summary

The current standard Swedish infection prophylaxis in colorectal surgery is intravenously administered cefuroxime and metronidazole. this combination is well studied. The disadvantages of the regimen is "collateral damage" resulting from treatment with a cephalosporine and that the combination also serves as the first line of treatment for abdominal surgical infections. Serval Swedish surgical departments have for some years used a combination of orally administered trimethoprim-sulfamethoxazole and metronidazole. The combination is economical and believed to be effective but hitherto the outcome have not been properly researched. The aim of this study is to compare the efficacy of these two regimens in the prevention of infection after elective colorectal surgery.

Timeline

Start
2007-09
Primary completion
2011-12
Completion
2012-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cefuroxime Small molecule 1500 mg Intravenous
Comparator Metronidazole Small molecule 1200 mg Oral
Comparator Metronidazole Small molecule 1500 mg Intravenous
Subject trimethoprim-sulfamethoxazole Unknown 160 mg Oral
Subject trimethoprim-sulfamethoxazole Unknown 800 mg Oral

Indications

No indication recorded.