Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-02-17 @ 5:50 PM
Study NCT ID:
NCT02703857
Status:
COMPLETED
Last Update Posted:
2017-06-12
First Post:
2016-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Repeated Cefoxitin Administration in Major Abdominal Surgery Using a Microdialysis Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002440', 'term': 'Cefoxitin'}], 'ancestors': [{'id': 'D002513', 'term': 'Cephamycins'}, {'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2016-09-20'}, 'lastUpdateSubmitDate': '2017-06-09', 'studyFirstSubmitDate': '2016-02-09', 'studyFirstSubmitQcDate': '2016-03-08', 'lastUpdatePostDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total and free plasma of cefoxitin after repeated injections', 'timeFrame': '48 hours'}, {'measure': 'Free tissue concentration of cefoxitin every 20 minutes after the beginning of injections', 'timeFrame': '48 hours'}, {'measure': 'Concentration of cefoxitin in urine after every injection', 'timeFrame': '48 hours'}], 'secondaryOutcomes': [{'measure': 'Percentage of time when tissue concentration of cefoxitin is higher than the minimal inhibitory concentration of target organisms', 'timeFrame': '48 hours'}, {'measure': 'Concentrations of antibiotic in peritoneal fluid', 'timeFrame': '48 hours'}, {'measure': 'Clearance of distribution of cefoxitin', 'timeFrame': '48 hours'}, {'measure': 'Clearance of elimination of cefoxitin', 'timeFrame': '48 hours'}, {'measure': 'Cmax of Cefoxitin', 'timeFrame': '48 hours'}, {'measure': 'Vd of distribution o cefoxitin', 'timeFrame': '48 hours'}, {'measure': 'Area under the curve of plasma and tissue concentration of cefoxitin', 'timeFrame': '48 hours'}]}, 'conditionsModule': {'conditions': ['Antibiotic Prophylaxis Surgery']}, 'referencesModule': {'references': [{'pmid': '31220258', 'type': 'DERIVED', 'citation': 'Boisson M, Torres BGS, Yani S, Couet W, Mimoz O, Dahyot-Fizelier C, Marchand S, Gregoire N. Reassessing the dosing of cefoxitin prophylaxis during major abdominal surgery: insights from microdialysis and population pharmacokinetic modelling. J Antimicrob Chemother. 2019 Jul 1;74(7):1975-1983. doi: 10.1093/jac/dkz139.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe main objective of the study is to describe the tissue and plasma pharmacokinetics of cefoxitin after repeated injections.\n\nThis 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.\n\nThey receive 2 g cefoxitin parenterally at least 30 minutes before the incision and then every 2 hours until closing.\n\nThe primary endpoints are:\n\n* Total and plasma free concentrations of cefoxitin 0, 10, 30, 60, 90, 120 minutes after start of each infusion cefoxitin\n* Tissue free concentrations of cefoxitin every 20 minutes after the start of the first infusion cefoxitin until skin closure\n* Urinary concentrations of cefoxitin'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent major abdominal surgery whose forseeable time exceeds 4 hours and requires an antibiotic prophylaxis by cefoxitin\n\nExclusion Criteria:\n\n* morbid obesity (BMI \\> 35 kg/m²)\n* severe renal impairment (clearance creatinine \\< 30ml/min)\n* beta lactam hypersensitivity\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT02703857', 'acronym': 'PROPHYLOXITINE', 'briefTitle': 'Study of Repeated Cefoxitin Administration in Major Abdominal Surgery Using a Microdialysis Technique', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'orgStudyIdInfo': {'id': 'PROPHYLOXITINE'}}, 'armsInterventionsModule': {'interventions': [{'name': 'cefoxitin', 'type': 'DRUG', 'description': 'Parenteral administration of 2g of cefoxitin at least 30 minutes before incision and then every 2 hours until closing'}]}, 'contactsLocationsModule': {'locations': [{'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'Centre Hospitalier de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}