PROPHYLOXITIN-Intermittent cefoxitin administration versus loading bolus followed by continuous infusion for the prevention of surgical site infection in colorectal surgery: a multicentre, double-blind, randomized controlled clinical trial

Phase 3

Recruiting

Conditions: Colorectal surgery

Interventions: Drug: Loading bolus of cefoxitin
Drug: Intermittent cefoxitin
Drug: Continuous infusion of cefoxitin
Drug: Intermittent placebo
Drug: Continuous infusion of placebo

Registration Number: 2024-515146-16-00

Lead Sponsor: Centre Hospitalier Universitaire De Poitiers

Brief Summary: The main objective is to demonstrate the superiority of a loading dose of cefoxitin followed by continuous infusion over standard of care boluses in reducing SSI within 30 days after colorectal surgery

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing, recruiting

Sex: Not specified

Target Recruitment: 2000

Inclusion Criteria

Adult patients (≥18 years)

Undergoing colorectal surgery (predictable duration > 90 min)

Patients benefiting from a Social Security system or benefiting from it through a third party

Free subject, without guardianship or curatorship or subordination

Having given their informed consent

Exclusion Criteria

Patients with known history of hypersensitivity to cefoxitin or others beta-lactams

Patients with extreme severe obesity (defined by a body mass index greater than 50 kg/m2)

Patients with severe renal insufficiency (clearance creatinine < 30ml/min)

Active bacterial infection at the time of surgery or recent antimicrobial therapy (up to 2 weeks before surgery) except for oral surgical antibiotic prophylaxis

Participation to another clinical trial aimed at reducing SSI

Patients already previously enrolled in this study

Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal/mechanical: per os, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy)

Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection

Study & Design

Study Type: INTERVENTIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group (recommended administration scheme)	Loading bolus of cefoxitin	Intermittent cefoxitin + Continuous infusion of placebo
Intervention group (innovative administration scheme)	Intermittent placebo	Continuous infusion of cefoxitin + Intermittent placebo
Control group (recommended administration scheme)	Intermittent cefoxitin	Intermittent cefoxitin + Continuous infusion of placebo
Intervention group (innovative administration scheme)	Loading bolus of cefoxitin	Continuous infusion of cefoxitin + Intermittent placebo
Intervention group (innovative administration scheme)	Continuous infusion of cefoxitin	Continuous infusion of cefoxitin + Intermittent placebo
Control group (recommended administration scheme)	Continuous infusion of placebo	Intermittent cefoxitin + Continuous infusion of placebo

Primary Outcome Measures

Name	Time	Method
Proportion of patients with any SSI within 30 days after surgery.		Proportion of patients with any SSI within 30 days after surgery.

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with each type of SSI (superficial, deep and/or organ–space infection)		Proportion of patients with each type of SSI (superficial, deep and/or organ–space infection)
Proportion of patients with surgical reintervention		Proportion of patients with surgical reintervention
Proportion of patients with anastomotic leak		Proportion of patients with anastomotic leak
Proportion of patients with postoperative complication according to the Dindo and Clavien classification		Proportion of patients with postoperative complication according to the Dindo and Clavien classification
Proportion of patients with Clostridium difficile infection		Proportion of patients with Clostridium difficile infection
Hospital readmission censored at day 30		Hospital readmission censored at day 30
Unexpected admission to the ICU censored at day 30		Unexpected admission to the ICU censored at day 30
Duration of hospital stay and hospital free days		Duration of hospital stay and hospital free days
All-causes mortality		All-causes mortality
Proportion of per operative adverse events		Proportion of per operative adverse events

Trial Locations

Locations (18): Assistance Publique Hopitaux De Paris
🇫🇷
Paris, France
CHRU De Nancy
🇫🇷
Nancy, France
Centre Hospitalier Universitaire De Saint Etienne
🇫🇷
Saint-Etienne, France
Hopital Prive Sevigne
🇫🇷
Cesson Sevigne, France
Centre Hospitalier Universitaire De Poitiers
🇫🇷
Poitiers, France
Centre Hospitalier Universitaire De Toulouse
🇫🇷
Toulouse, France
Centre Hospitalier Universitaire Grenoble Alpes
🇫🇷
Grenoble Cedex 9, France
Hospices Civils De Lyon
🇫🇷
Lyon Cedex 02, France
Les Hopitaux Universitaires De Strasbourg
🇫🇷
Strasbourg Cedex, France
Centre Hospitalier Universitaire De Caen Normandie
🇫🇷
Caen Cedex 9, France
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Assistance Publique Hopitaux De Paris
🇫🇷Paris, France
Jean-Sébastien AUBERT
Site contact
0156092596
jean-sebastien.aubert@aphp.fr