drugset / Trial / NCT02445859

Continuous Antibiotic Prophylaxis in Colorectal Surgery

NCT02445859

Phase 2 Completed 90 enrolled University of Leeds
RandomizedParallel-groupSingle-blindPrevention

Summary

We propose to randomise patients due to undergo colorectal surgery to standard antibiotic prophylaxis or an interventional antibiotic prophylaxis regimen and assess surgical wound infection rates. Standard antibiotic prophylaxis is a pre-operative injection of cefuroxime, repeated every 4 hours. The intervention regimen is a loading dose of cefuroxime followed by a continuous infusion of cefuroxime until the end of surgery. The intervention regimen dosing will be calculated using a patient's renal function and body weight. The intervention regimen will target a free serum drug concentration of 64mg/L. This serum level is 4x the MIC90 for colonising Enterobacteriaceae. The rational for this dosing regimen is summarised below. The primary objective of the study is to reduce by 50% the rate of surgical wound infections after colorectal surgery.

Timeline

Start
2015-08
Primary completion
2017-05
Completion
2017-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Cefuroxime Small molecule 1.5 g Other

Indications

No indication recorded.