Pharmacokinetic Study of Vancomycin, Clindamycin And/or Gentamicin Administration During Surgery Using a Microdialysis Procedure

Phase 1

Completed

• Conditions: Surgical Site Infection

• Registration Number: NCT03845790
• Lead Sponsor: Poitiers University Hospital

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 way to prevent surgical site infections. The beta-lactam are the most frequent antibiotics recommended for surgical prophylaxis and patients known to be allergic to beta-lactam are more likely to presented surgical site infection, probably due to use of others antibiotic such as vancomycin or clindamycin.

The main objective of the study is to describe the tissu and plasma pharmacokinetics of vancomycin, clindamycin and gentamicin using as surgical antibiotic prophylaxis in patients with beta-lactam hypersensivity and to predict the probability of target attainment for usual bacteria.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-15
• Study First Submitted QC: 2019-02-15
• Study First Posted: 2019-02-19
• Study Start: 2019-05-26
• Primary Completion: 2024-09-04
• Study Completion: 2024-09-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Adult patient between 18 and 80 years old
• Patient with history of beta-lactam hypersensitivity
• Patient who underwent abdominal or orthopedic surgery whose forseeable time exceeds 1 hour and requires a surgical antibiotic prophylaxis by vancomycin or clindamycin + gentamicin

Exclusion Criteria

• morbid obesity (BMI > 35 kg/m2)
• mild to severe renal impairment (clearance creatinine < 60 ml/min)
• vancomycin, clindamycin or gentamicin hypersensitivity
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Total and free plasma of vancomycin, clindamycin or gentamicin	24 hours
Probability of target attainment of PK/PD index for usual bacteria (AUC/CMI >1 for vancomycin and clindamycin, Cmax/CMI >8 for gentamicin) with the recommended dosing regimen	2 days
Free tissue concentration of vancomycin, clindamycin or gentamicin every 20 minutes after the beginning of injections	24 hours

Secondary Outcome Measures

Name	Time	Method
Probability of target attainment of PK/PD index for usual bacteria (AUC/CMI >1 for vancomycin and clindamycin, Cmax/CMI >8 for gentamicin) with new simulated dosing regimens.	2 days

Trial Locations

Locations (1)

CHU de Poitiers; 🇫🇷 Poitiers, France