Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-01-31 @ 12:35 PM
Study NCT ID:
NCT02882568
Status:
COMPLETED
Last Update Posted:
2017-12-21
First Post:
2016-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Immune Response In Bacterial Infection of Obese Subject
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-19', 'studyFirstSubmitDate': '2016-06-14', 'studyFirstSubmitQcDate': '2016-08-24', 'lastUpdatePostDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patterns of inflammatory and immunological markers in obese patients in sepsis and post- sepsis ("normal") situation', 'timeFrame': 'T 0 and at 1 month', 'description': 'Standard inflammatory markers; immunological markers (cytokines, leptine, lymphocyte phenotype)'}], 'secondaryOutcomes': [{'measure': 'Evaluation of sepsis; correlation with inflammatory and immunological parameters', 'timeFrame': 'T 0 and at 1 month'}, {'measure': 'Analysis of leptine polymorphism', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'Improve knowledge of the immune response to sepsis in obese patients. Define immunological and genetic prognostic factors of severe infections which can motivate a change in the therapeutic attitude'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* between18 and 80 years\n* obesity: BMI \\> 30\n* presumed bacterial infection:\n\n * pneumonitis (documented or probably)\n * pyelonephritis / acute prostatitis\n * soft tissue / skin infection (except for bedsore)\n * cholecystitis / angiocholitis\n * meningitis\n * clostridium colitis\n * surgical site infection\n* signed consent\n\nExclusion Criteria:\n\n* patients with viral, parasitic or mycotic documented infection\n* patients with bacterial infection with treatment\\> 4 weeks (ex. endocarditis; osteo- articular infections)\n* patients with prior antibiotic treatment (\\< 14 days)\n* intensive care unit patients\n* patients with a history of cancer or malignant hematological disease within the 5 previous years that is currently clinically significant (non metastatic prostatic and basocellular malignancy are excluded)\n* patients with systemic disease\n* Known diagnosis of human immunodeficiency infection (DICV, HIV…)\n* immunosuppression treatment during last month including corticotherapy\n* pregnancy\n* 3 months follow up not possible\n* non signed consent'}, 'identificationModule': {'nctId': 'NCT02882568', 'acronym': 'ARIIBO', 'briefTitle': 'Analysis of Immune Response In Bacterial Infection of Obese Subject', 'organization': {'class': 'OTHER', 'fullName': 'Versailles Hospital'}, 'officialTitle': 'Analysis of Immune Response In Bacterial Infection of Obese Subject', 'orgStudyIdInfo': {'id': 'P15/19_ARIIBO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'investigational', 'description': 'Blood test for Inflammatory and immunological analysis during acute sepsis phase and one month later', 'interventionNames': ['Biological: blood analysis']}], 'interventions': [{'name': 'blood analysis', 'type': 'BIOLOGICAL', 'description': 'Pilot study, single center, interventional including 15 obese subjects with acute sepsis. Inflammatory and immunological tests during acute phase and one month later after a presumed return parameters at baseline', 'armGroupLabels': ['investigational']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Le Chesnay', 'country': 'France', 'facility': 'Ch de Versailles', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Versailles Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Roderick Meckenstock', 'investigatorAffiliation': 'Versailles Hospital'}}}}