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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03845790

Enrollment

Registered

2019-02-19

Start date

2019-05-26

Completion date

2024-09-04

Last updated

2025-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Site Infection

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.

Interventions

OTHERBlood and microdialysis samples

Blood and microdialisys pharmacocinetic samples on one of the two antibiotics prescribed in routine use

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Intervention model description

Pharmacokinetic study

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Total and free plasma of vancomycin, clindamycin or gentamicin	24 hours
Free tissue concentration of vancomycin, clindamycin or gentamicin every 20 minutes after the beginning of injections	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

Secondary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026