Study of Repeated Cefoxitin Administration in Major Abdominal Surgery Using a Microdialysis Technique

NCT02703857 | Completed Phase 4

• 1 other identifier: PROPHYLOXITINE
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The surgical site infection is one of the most important causes of postoperative morbidity. The appropriate antibiotic prophylaxis is one of the most effective ways to prevent surgical site infections. The recommendations of the French Society of Anesthesia Resuscitation on antibiotic prophylaxis in long surgeries are based on low documentation, including frequency and dosage of reinjection. The main objective of the study is to describe the tissue and plasma pharmacokinetics of cefoxitin after repeated injections. This is an open monocentric study (phase 4) including adults aged 18 to 80 years in need of major abdominal surgery whose foreseeable time exceeds 4 hours and justifying an antibiotic prophylaxis by cefoxitin. They receive 2 g cefoxitin parenterally at least 30 minutes before the incision and then every 2 hours until closing. The primary endpoints are:

• Total and plasma free concentrations of cefoxitin 0, 10, 30, 60, 90, 120 minutes after start of each infusion cefoxitin
• Tissue free concentrations of cefoxitin every 20 minutes after the start of the first infusion cefoxitin until skin closure
• Urinary concentrations of cefoxitin

Conditions

Antibiotic Prophylaxis Surgery

Outcome Measures

Primary Outcomes (3)

• Total and free plasma of cefoxitin after repeated injections

  48 hours

• Free tissue concentration of cefoxitin every 20 minutes after the beginning of injections

  48 hours

• Concentration of cefoxitin in urine after every injection

  48 hours

Secondary Outcomes (7)

• Percentage of time when tissue concentration of cefoxitin is higher than the minimal inhibitory concentration of target organisms

  48 hours

• Concentrations of antibiotic in peritoneal fluid

  48 hours

• Clearance of distribution of cefoxitin

  48 hours

• Clearance of elimination of cefoxitin

  48 hours

• Cmax of Cefoxitin

  48 hours

Interventions

cefoxitin DRUG

Parenteral administration of 2g of cefoxitin at least 30 minutes before incision and then every 2 hours until closing

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who underwent major abdominal surgery whose forseeable time exceeds 4 hours and requires an antibiotic prophylaxis by cefoxitin

You may not qualify if:

• morbid obesity (BMI \> 35 kg/m²)
• severe renal impairment (clearance creatinine \< 30ml/min)
• beta lactam hypersensitivity
• pregnancy

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

Centre Hospitalier de Poitiers

Poitiers, 86021, France

Location

Related Publications (1)

• Boisson M, Torres BGS, Yani S, Couet W, Mimoz O, Dahyot-Fizelier C, Marchand S, Gregoire N. Reassessing the dosing of cefoxitin prophylaxis during major abdominal surgery: insights from microdialysis and population pharmacokinetic modelling. J Antimicrob Chemother. 2019 Jul 1;74(7):1975-1983. doi: 10.1093/jac/dkz139.

  PMID: 31220258 DERIVED

MeSH Terms

Interventions

Cefoxitin

Intervention Hierarchy (Ancestors)

Cephamycins; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: March 9, 2016
• Study Start: February 1, 2016
• Primary Completion: September 15, 2016
• Study Completion: September 20, 2016
• Last Updated: June 12, 2017

Record last verified: 2017-06

Locations

FR (1)