Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT01551667
Status:
COMPLETED
Last Update Posted:
2016-04-06
First Post:
2012-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immune Response of Patients With Chronic, Staphylococcus Aureus-infected Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D016470', 'term': 'Bacteremia'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D013203', 'term': 'Staphylococcal Infections'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D005534', 'term': 'Foot Diseases'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Left over blood/serum/plasma specimens will be incorporated into the biobank at the Bacteriology Laboratory of the Nîmes University Hospital'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-05', 'studyFirstSubmitDate': '2012-03-06', 'studyFirstSubmitQcDate': '2012-03-12', 'lastUpdatePostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Humoral immune response', 'timeFrame': '6 months', 'description': 'Humoral immune response via production of anti-staphylococci antibodies in patients with bacteraemia versus those with localized wound infections. 22 antibodies will be tested(quantitative determination by xMAP technology).'}], 'secondaryOutcomes': [{'measure': 'Antibody production kinetics', 'timeFrame': '6 months', 'description': 'Kinetics of the production of the 22 antibodies against S. aureus in the 2 groups. The temporal evolution of antibody titres determined via xMAP technology will be followed throughout the study.'}, {'measure': 'Presence / absence of clonal complexes of the S. aureus strains', 'timeFrame': '6 months', 'description': 'determined by microarrays'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['S. aureus'], 'conditions': ['Diabetic Foot', 'Foot Ulcer', 'Leg Ulcer', 'Bacteremia', 'Infection']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to detect differences in anti-S. aureus antibody assays (IgM, IgA, IgG and its subclasses) between (1) a group of patients with bacteremia due to a chronic wound (cases) and (2) a group of patients with localized chronic wound infections (control).', 'detailedDescription': 'Secondary objectives include:\n\n* To propose a diagnostic marker of bacteraemia based on the detection of anti-S. aureus by xMAP technology\n* To evaluate the kinetics of the humoral immune response to S. aureus in patients with bacteraemia\n* To evaluate the virulence of S. aureus isolated from chronic, infected wounds\n* To enrich the Nîmes University Hospital biobank\n* To evaluate the prevalence of different antibodies within each group'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients consulting at the departments of Diabetology, Dermatology or Infectious Diseases of the participating hospitals and who have (1) inaugural or recurrent diabetic foot/ankle ulcers of Grade 2-4, or (2) who have an infected leg ulcer (arterial, venous, or mixed). This infection must involve S. aureus in a mono-or polymicrobial setting.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patient must have given his/her informed and signed consent\n* The patient must be insured or beneficiary of a health insurance plan\n* The patient is available for 6 months of follow up\n* Patients consulting at the departments of Diabetology, Dermatology or Infectious Diseases of the participating hospitals\n* inaugural or recurrent diabetic foot/ankle ulcers of Grade 2-4, or (2) who have an infected leg ulcer (arterial, venous, or mixed.\n\nControls:\n\n* Absence of bacteriemia\n\nCases:\n\n* Presence of bacteriemia\n\nExclusion Criteria:\n\n* The patient is participating in another study\n* The patient is in an exclusion period determined by a previous study\n* The patient is under judicial protection, under tutorship or curatorship\n* The patient refuses to sign the consent\n* It is impossible to correctly inform the patient\n* The patient is pregnant, parturient, or breastfeeding\n* The patient does not have a chronic wound\n* Patient with grand 1 ulcer\n* Patient's wound/ulcer is not infected\n* Patient's would/ulcer is infected, but not involving S. aureus"}, 'identificationModule': {'nctId': 'NCT01551667', 'acronym': 'ORISA', 'briefTitle': 'Immune Response of Patients With Chronic, Staphylococcus Aureus-infected Wounds', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Observational and Comparative Study on the Immune Response of Patients With Chronic, Staphylococcus Aureus-infected Wounds (Localized Infections Versus Bacteremia)', 'orgStudyIdInfo': {'id': 'AOI/2011/JPL-02'}, 'secondaryIdInfos': [{'id': '2011-A01400-41', 'type': 'OTHER', 'domain': 'RCB number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases / bacteraemia', 'description': 'Patients consulting at the departments of Diabetology, Dermatology or Infectious Diseases of the participating hospitals and who have (1) inaugural or recurrent diabetic foot/ankle ulcers of Grade 2-4, or (2) who have an infected leg ulcer (arterial, venous, or mixed. This infection must involve S. aureus in a mono-or polymicrobial setting. This group of patients has bacteraemia.', 'interventionNames': ['Biological: Antibody assays for S. aureus', 'Biological: Basic blood work']}, {'label': 'Controls', 'description': 'Patients consulting at the departments of Diabetology, Dermatology or Infectious Diseases of the participating hospitals and who have (1) inaugural or recurrent diabetic foot/ankle ulcers of Grade 2-4, or (2) who have an infected leg ulcer (arterial, venous, or mixed. This infection must involve S. aureus in a mono-or polymicrobial setting. This group of patients does not have bacteraemia.', 'interventionNames': ['Biological: Antibody assays for S. aureus', 'Biological: Basic blood work']}], 'interventions': [{'name': 'Antibody assays for S. aureus', 'type': 'BIOLOGICAL', 'description': 'Antibody assays for S. aureus at Day 0, Day 2, Day 4, Day 7, Day 30 and Month 6.', 'armGroupLabels': ['Cases / bacteraemia', 'Controls']}, {'name': 'Basic blood work', 'type': 'BIOLOGICAL', 'description': 'Hemogramme + CRP on Days 0, 2, 4 and 7', 'armGroupLabels': ['Cases / bacteraemia', 'Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'state': 'Gard', 'country': 'France', 'facility': 'CHU de Nîmes - Hôpital Universitaire Carémeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '30240', 'city': 'Le Grau-du-Roi', 'country': 'France', 'facility': 'CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi', 'geoPoint': {'lat': 43.53881, 'lon': 4.13559}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU de Montpellier - Hôpital Saint-Eloi', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU de Nantes - Hôtel-Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06002', 'city': 'Nice', 'country': 'France', 'facility': 'CHU de Nice - Hôpital Pasteur', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '06202', 'city': 'Nice', 'country': 'France', 'facility': "CHU de Nice - Hôpitaux L'Archet 1 et 2", 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Jean-Philippe Lavigne, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}