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

NCT03845790 | Completed Phase 1

• 1 other identifier: PK PROPHYLAXIE
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• 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

Interventions

Blood and microdialysis samples OTHER

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU de Poitiers

Poitiers, France

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pharmacokinetic study

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 19, 2019
• Study Start: May 26, 2019
• Primary Completion: September 4, 2024
• Study Completion: September 4, 2024
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)