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

Antibiotic Prophylaxis Surgery Clinical Trial

— PROPHYLOXITINE  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02703857
• Other study ID #: PROPHYLOXITINE
• Status: Completed
• Phase: Phase 4
• First received: February 9, 2016
• Last updated: June 9, 2017
• Start date: February 2016
• Est. completion date: September 20, 2016

Study information

• Verified date: June 2017
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 20, 2016
• Est. primary completion date: September 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• morbid obesity (BMI > 35 kg/m²)

• severe renal impairment (clearance creatinine < 30ml/min)

• beta lactam hypersensitivity

• pregnancy

Related Conditions & MeSH terms

• Antibiotic Prophylaxis Surgery

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total and free plasma of cefoxitin after repeated injections		48 hours
Primary	Free tissue concentration of cefoxitin every 20 minutes after the beginning of injections		48 hours
Primary	Concentration of cefoxitin in urine after every injection		48 hours
Secondary	Percentage of time when tissue concentration of cefoxitin is higher than the minimal inhibitory concentration of target organisms		48 hours
Secondary	Concentrations of antibiotic in peritoneal fluid		48 hours
Secondary	Clearance of distribution of cefoxitin		48 hours
Secondary	Clearance of elimination of cefoxitin		48 hours
Secondary	Cmax of Cefoxitin		48 hours
Secondary	Vd of distribution o cefoxitin		48 hours
Secondary	Area under the curve of plasma and tissue concentration of cefoxitin		48 hours