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

Study Overview
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Brief Summary
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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.

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

Conditions
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Surgical Site Infection

Intervention / Treatment
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* Other: Blood and microdialysis samples


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Pharmacokinetic study
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Blood and microdialysis samples|Blood and microdialisys pharmacocinetic samples on one of the two antibiotics prescribed in routine use|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |