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

Surgical Site Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03845790
• Other study ID #: PK PROPHYLAXIE
• Status: Recruiting
• Phase: Phase 1
• Start date: May 26, 2019
• Est. completion date: November 26, 2024

Study information

• Verified date: November 2023
• Source: Poitiers University Hospital
• Contact: Matthieu BOISSON
• Phone: 0033.549.442.517
• Email: Matthieu.BOISSON[@]chu-poitiers.fr
• 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: November 26, 2024
• Est. primary completion date: November 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgical Site Infection
• Surgical Wound Infection

Intervention

Other:
• Blood and microdialysis samples
Blood and microdialisys pharmacocinetic samples on one of the two antibiotics prescribed in routine use

Locations

Country	Name	City	State
France	CHU 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 vancomycin, clindamycin or gentamicin		24 hours
Primary	Free tissue concentration of vancomycin, clindamycin or gentamicin every 20 minutes after the beginning of injections		24 hours
Primary	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	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