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PROPHYLOXITIN: Continuous vs Intermittent Cefoxitin in Colorectal Surgery
NCT05755789Phase 3
Key facts
- Status
- Recruiting
- Start
- Jun 2023
- Primary completion
- May 2025
- Countries
- 1
- Sponsor
- CHU de Poitiers
- Modality
- Small Molecules
- Drugs
- cefoxitin
- Conditions
- surgical site infection (SSI)
01
Overview
Phase 3, randomised, double-blind trial of cefoxitin in surgical site infection (SSI) (2 arms), sponsored by CHU de Poitiers. Primary endpoint: Surgical site infection at 30 days. Started Jun 2023; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Continuous Cefoxitin
Loading bolus 2g + Continuous infusion 0.5g/h
Intermittent Cefoxitin
Loading bolus 2g + Intermittent bolus 1g q2h
03
Who it enrols
Adult patients undergoing colorectal surgery with a predictable duration > 90 minutes. Patients with severe obesity (BMI > 50), severe renal insufficiency (creatinine clearance < 30 ml/min), active bacterial infection, or history of hypersensitivity to cefoxitin or beta-lactams are excluded.
04
Endpoints
Primary
Surgical site infection
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