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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood and microdialysis samples | Other | Blood and microdialisys pharmacocinetic samples on one of the two antibiotics prescribed in routine use |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Poitiers | Poitiers | France |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Pharmacokinetic study
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |