Study of Repeated Cefoxitin Administration in Major Abdominal Surgery Using a Microdialysis Technique (PROPHYLOXITINE)
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|ClinicalTrials.gov Identifier: NCT02703857|
Recruitment Status : Completed
First Posted : March 9, 2016
Last Update Posted : June 12, 2017
The surgical site infection is one of the most important causes of postoperative morbidity. The appropriate antibiotic prophylaxis is one of the most effective ways to prevent surgical site infections. The recommendations of the French Society of Anesthesia Resuscitation on antibiotic prophylaxis in long surgeries are based on low documentation, including frequency and dosage of reinjection.
The main objective of the study is to describe the tissue and plasma pharmacokinetics of cefoxitin after repeated injections.
This is an open monocentric study (phase 4) including adults aged 18 to 80 years in need of major abdominal surgery whose foreseeable time exceeds 4 hours and justifying an antibiotic prophylaxis by cefoxitin.
They receive 2 g cefoxitin parenterally at least 30 minutes before the incision and then every 2 hours until closing.
The primary endpoints are:
- Total and plasma free concentrations of cefoxitin 0, 10, 30, 60, 90, 120 minutes after start of each infusion cefoxitin
- Tissue free concentrations of cefoxitin every 20 minutes after the start of the first infusion cefoxitin until skin closure
- Urinary concentrations of cefoxitin
|Condition or disease||Intervention/treatment||Phase|
|Antibiotic Prophylaxis Surgery||Drug: cefoxitin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||February 2016|
|Actual Primary Completion Date :||September 15, 2016|
|Study Completion Date :||September 20, 2016|
- Drug: cefoxitin
Parenteral administration of 2g of cefoxitin at least 30 minutes before incision and then every 2 hours until closing
- Total and free plasma of cefoxitin after repeated injections [ Time Frame: 48 hours ]
- Free tissue concentration of cefoxitin every 20 minutes after the beginning of injections [ Time Frame: 48 hours ]
- Concentration of cefoxitin in urine after every injection [ Time Frame: 48 hours ]
- Percentage of time when tissue concentration of cefoxitin is higher than the minimal inhibitory concentration of target organisms [ Time Frame: 48 hours ]
- Concentrations of antibiotic in peritoneal fluid [ Time Frame: 48 hours ]
- Clearance of distribution of cefoxitin [ Time Frame: 48 hours ]
- Clearance of elimination of cefoxitin [ Time Frame: 48 hours ]
- Cmax of Cefoxitin [ Time Frame: 48 hours ]
- Vd of distribution o cefoxitin [ Time Frame: 48 hours ]
- Area under the curve of plasma and tissue concentration of cefoxitin [ Time Frame: 48 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02703857
|Centre Hospitalier de Poitiers|
|Poitiers, France, 86021|