Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-30 @ 12:45 AM
Study NCT ID:
NCT00699868
Status:
COMPLETED
Last Update Posted:
2012-06-04
First Post:
2008-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Response and Cytomegalovirus in Intensive Care Unit (ICU) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003586', 'term': 'Cytomegalovirus Infections'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-01', 'studyFirstSubmitDate': '2008-06-13', 'studyFirstSubmitQcDate': '2008-06-17', 'lastUpdatePostDateStruct': {'date': '2012-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bring to light the quantitative and qualitative immunological modifications of the present cells NK before the arisen of an infection to CMV', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Bring to light the quantitative and qualitative immunological modifications of cells NK in the consequences of an infectious shock', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cytomegalovirus Infection']}, 'referencesModule': {'references': [{'pmid': '23687088', 'type': 'DERIVED', 'citation': 'Matta J, Baratin M, Chiche L, Forel JM, Cognet C, Thomas G, Farnarier C, Piperoglou C, Papazian L, Chaussabel D, Ugolini S, Vely F, Vivier E. Induction of B7-H6, a ligand for the natural killer cell-activating receptor NKp30, in inflammatory conditions. Blood. 2013 Jul 18;122(3):394-404. doi: 10.1182/blood-2013-01-481705. Epub 2013 May 17.'}, {'pmid': '23236375', 'type': 'DERIVED', 'citation': 'Forel JM, Chiche L, Thomas G, Mancini J, Farnarier C, Cognet C, Guervilly C, Daumas A, Vely F, Xeridat F, Vivier E, Papazian L. Phenotype and functions of natural killer cells in critically-ill septic patients. PLoS One. 2012;7(12):e50446. doi: 10.1371/journal.pone.0050446. Epub 2012 Dec 6.'}]}, 'descriptionModule': {'briefSummary': 'This prospective study evaluate the immune status of patients admitted in ICU.CMV remains dormant in the body, but in people with immune deficiency, CMV could reactivate and cause life-threatening pneumonia.', 'detailedDescription': 'Candidates will be screened with medical history and blood tests.Then, 2 groups of 20 patients (with or without CMV reactivation) matched for CMV status will be compared for their immune system against CMV.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age more than 18-year-old\n* Informed consent\n\nExclusion Criteria:\n\n* minors,\n* pregnant or lactating women,\n* adults under guardianship,\n* immunosuppression at the entrance to resuscitation,\n* AIDS'}, 'identificationModule': {'nctId': 'NCT00699868', 'acronym': '2006/25', 'briefTitle': 'Immune Response and Cytomegalovirus in Intensive Care Unit (ICU) Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Cellular Immunity, Cytomegalovirus Infection and Septic Shock in ICU Patients', 'orgStudyIdInfo': {'id': '2007-A01197-46'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Infection to CMV', 'interventionNames': ['Other: Sampling of blood, phenotypic analysis sub-populations NK by cytometric of stream in multiple markings']}, {'type': 'OTHER', 'label': '2', 'description': 'Group "control CMV"', 'interventionNames': ['Other: Sampling of blood, phenotypic analysis sub-populations NK by cytometric of stream in multiple markings']}], 'interventions': [{'name': 'Sampling of blood, phenotypic analysis sub-populations NK by cytometric of stream in multiple markings', 'type': 'OTHER', 'description': 'Sampling of blood', 'armGroupLabels': ['1']}, {'name': 'Sampling of blood, phenotypic analysis sub-populations NK by cytometric of stream in multiple markings', 'type': 'OTHER', 'description': 'Sampling of blood', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13009', 'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital de Sainte Marguerite- Service de Réanimation Médicale', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'Jean-Marie FOREL, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique des Hôpitaux de Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Assistance Publique Hopitaux De Marseille', 'oldOrganization': 'Assistance Publique Hopitaux De Marseille'}}}}