Back to resultsIntermittent Cefoxitin Administration Versus Loading Bolus Followed by Continuous Infusion for the Prevention of Surgical Site Infection in Colorectal Surgery (PROPHYLOXITIN)
Primary Purpose
Antibiotic Prophylaxis, Colorectal Surgery
Status
Not yet recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Loading bolus of cefoxitin
Intermittent cefoxitin
Continuous infusion of placebo
Continuous infusion of cefoxitin
Intermittent placebo
Sponsored by
About this trial
This is an interventional prevention trial for Antibiotic Prophylaxis focused on measuring cefoxitin
Eligibility Criteria
Inclusion Criteria: Adult patients (≥18 years) Undergoing colorectal surgery (predictable duration > 90 min) Exclusion Criteria: Patients with known history of hypersensitivity to cefoxitin or others beta-lactams Patients with severe obesity (defined by a body mass index greater than 35 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
Sites / Locations
- Centre Hospitalier de Poitiers
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group (innovative administration scheme)
Control group (recommended administration scheme)
Arm Description
Continuous infusion of cefoxitin + Intermittent placebo
Intermittent cefoxitin + Continuous infusion of placebo
Outcomes
Primary Outcome Measures
Surgical site infection
Proportion of patients with any surgical site infection according to the CDC criteria
Secondary Outcome Measures
Full Information
NCT ID
NCT05755789
First Posted
February 23, 2023
Last Updated
March 10, 2023
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05755789
Brief Title
Intermittent Cefoxitin Administration Versus Loading Bolus Followed by Continuous Infusion for the Prevention of Surgical Site Infection in Colorectal Surgery
Acronym
PROPHYLOXITIN
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The goal of this prospective, multicentre, double-blind, randomized clinical trial is to compare intermittent cefoxitin administration to loading bolus followed by continuous infusion for surgical antibiotic prophylaxis in colorectal surgery.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antibiotic Prophylaxis, Colorectal Surgery
Keywords
cefoxitin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group (innovative administration scheme)
Arm Type
Experimental
Arm Description
Continuous infusion of cefoxitin + Intermittent placebo
Arm Title
Control group (recommended administration scheme)
Arm Type
Active Comparator
Arm Description
Intermittent cefoxitin + Continuous infusion of placebo
Intervention Type
Drug
Intervention Name(s)
Loading bolus of cefoxitin
Intervention Description
Cefoxitin [2g] at least 30 min before incision
Intervention Type
Drug
Intervention Name(s)
Intermittent cefoxitin
Intervention Description
Additional bolus of cefoxitin [1g] every 2 hours until the end of surgical closure
Intervention Type
Drug
Intervention Name(s)
Continuous infusion of placebo
Intervention Description
Continuous infusion of placebo from the end of the loading bolus until the end of surgical closure
Intervention Type
Drug
Intervention Name(s)
Continuous infusion of cefoxitin
Intervention Description
Continuous infusion of cefoxitin [0.5g/h] from the end of the loading bolus until the end of surgical closure
Intervention Type
Drug
Intervention Name(s)
Intermittent placebo
Intervention Description
Additional bolus of placebo every 2 hours until the end of surgical closure
Primary Outcome Measure Information:
Title
Surgical site infection
Description
Proportion of patients with any surgical site infection according to the CDC criteria
Time Frame
within 30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients (≥18 years)
Undergoing colorectal surgery (predictable duration > 90 min)
Exclusion Criteria:
Patients with known history of hypersensitivity to cefoxitin or others beta-lactams
Patients with severe obesity (defined by a body mass index greater than 35 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthieu BOISSON, MD-PhD
Phone
+33549444635
Email
matthieu.boisson@chu-poitiers.fr
Facility Information:
Facility Name
Centre Hospitalier de Poitiers
City
Poitiers
State/Province
Vienne
ZIP/Postal Code
86021
Country
France
12. IPD Sharing Statement
Learn more about this trial
Intermittent Cefoxitin Administration Versus Loading Bolus Followed by Continuous Infusion for the Prevention of Surgical Site Infection in Colorectal Surgery
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