Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-01-13 @ 9:26 AM
Study NCT ID:
NCT03310606
Status:
UNKNOWN
Last Update Posted:
2019-01-18
First Post:
2017-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum and Peritoneal Concentration in Antibiotics During the Surgical Management of Peritonitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010538', 'term': 'Peritonitis'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-17', 'studyFirstSubmitDate': '2017-08-28', 'studyFirstSubmitQcDate': '2017-10-13', 'lastUpdatePostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum and peritoneal beta lactams concentrations at 3 times', 'timeFrame': '3 times : Peritoneal incision, Admission in ICU and 24 hours after admission in ICU', 'description': 'Population : patients with surgical peritonitis. The concentrations are compared with the minimum inhibitory concentrations of bacteria to diagnose a sub therapeutic dosage.'}], 'secondaryOutcomes': [{'measure': 'Factors associated with an antibiotic under-dosage', 'timeFrame': 'Statistical analysis after 2 years of inclusion', 'description': 'effect of presence of septic shock on antibiotic concentration'}, {'measure': 'Factors associated with an antibiotic under-dosage', 'timeFrame': 'Statistical analysis after 2 years of inclusion', 'description': 'effect of volume ressucitation on antibiotic concentration'}, {'measure': 'Factors associated with an antibiotic under-dosage', 'timeFrame': 'Statistical analysis after 2 years of inclusion', 'description': 'effect of renal function on antibiotic concentration'}, {'measure': 'Evaluate the relationship between serum and peritoneal concentrations of beta-lactam', 'timeFrame': 'Statistical analysis after 2 years of inclusion', 'description': 'Determination of the antibiotic diffusion coefficient through the peritoneal membrane : difference between serum concentration and peritoneal concentration of B lactam'}, {'measure': 'Morbidity of included patients', 'timeFrame': 'Reception on the 8th postoperative day', 'description': 'Morbidity is assessed by the presence or absence of second peritonitis surgery during hospitalization in ICU and at most 8 days (the mean of the peritonitis stays in the ICU of the investigators in 2016 is 8 days)'}, {'measure': 'Mortality of included patients', 'timeFrame': 'Reception on the 8th postoperative day', 'description': 'The mortality is evaluated by the presence or absence of the death of the patient during the hospitalization in ICU and at most 8 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Therapeutic drug monitoring'], 'conditions': ['Peritonitis', 'Critical Illness']}, 'referencesModule': {'references': [{'pmid': '31599951', 'type': 'DERIVED', 'citation': 'Leon L, Guerci P, Pape E, Thilly N, Luc A, Germain A, Butin-Druoton AL, Losser MR, Birckener J, Scala-Bertola J, Novy E. Serum and peritoneal exudate concentrations after high doses of beta-lactams in critically ill patients with severe intra-abdominal infections: an observational prospective study. J Antimicrob Chemother. 2020 Jan 1;75(1):156-161. doi: 10.1093/jac/dkz407.'}]}, 'descriptionModule': {'briefSummary': "SPAC is a pilote monocentric prospective study about peritonitis and antibiotics pharmacokinetic and pharmacodynamic. The investigators will included 50 patients during 2 years in the University Hospital of Nancy.\n\nThe aim of this study is to determine if the beta-lactam dosages recommended by the guidelines for management of intra-abdominal infections (published by the Société française d'anesthésie et de réanimation (Sfar) in december 2015) permitted the achievement of adequatly serum and peritoneal concentrations in the medical and surgical management of peritonitis.\n\nThe investigators will collected 3 pairs of serum and peritoneal fluid samples at 3 different times: peritoneal incision, arrival in ICU and 24 hours after admission in ICU in order to compare the concentrations and the minimal inhibitor concentration of bacteria.\n\nThe hypothesis is that of a serum and peritoneal antibiotic under dosage."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minimun age limits 18 years\n* All sex\n* Patients with peritonitis (community or nosocomial) regardless of pathology involved\n* Patients treated in the Universty Hospital of Vandoeuvre les Nancy (abdominal surgery unit and surgical Intensive care unit JM Picard)\n\nExclusion Criteria:\n\n* Beta lactam allergy\n* Pregnancy\n* Age less than 18 years\n* No respect of recommandations for antibiotics ( molecule and dosage)\n* Person under legal protection'}, 'identificationModule': {'nctId': 'NCT03310606', 'acronym': 'SPAC', 'briefTitle': 'Serum and Peritoneal Concentration in Antibiotics During the Surgical Management of Peritonitis', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Serum and Peritoneal Concentration in Antibiotics During the Surgical Management of Peritonitis: SPAC', 'orgStudyIdInfo': {'id': '2017-A00710-53'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Peritonitis', 'description': 'Patient received for antibiotic treatment a B lactam according to French recommendation :\n\n* type of antibiotic : cefotaxime or ceftriaxone or piperacilline/tazobactam or imipenem\n* dose : cefotaxime 2g / cetriaxone 2g / piperacilline 4g / imipenem 1g', 'interventionNames': ['Other: Dosage of serum and peritoneal of the B lactam used for antibiotic treatment']}], 'interventions': [{'name': 'Dosage of serum and peritoneal of the B lactam used for antibiotic treatment', 'type': 'OTHER', 'description': 'Dosage of serum and peritoneal of the B lactam used B lactam concerning are : CEFTRIAXONE, CEFOTAXIME, PIPERACILLINE/TAZOBACTAM, IMIPENEM', 'armGroupLabels': ['Peritonitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emmanuel NOVY, MD', 'role': 'CONTACT', 'email': 'e.novy@chru-nancy.fr', 'phone': '+33 383157437'}], 'facility': 'Central Hospital', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'centralContacts': [{'name': 'Emmanuel NOVY, MD', 'role': 'CONTACT', 'email': 'e.novy@chru-nancy.fr', 'phone': '+33 3157437'}, {'name': 'El Mehdi SIAGHY', 'role': 'CONTACT', 'email': 'm.siaghy@chru-nancy.fr', 'phone': '+33 3155276'}], 'overallOfficials': [{'name': 'Emmanuel NOVY, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU NANCY'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}