Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-01-01 @ 3:41 AM
Study NCT ID:
NCT04043793
Status:
COMPLETED
Last Update Posted:
2022-10-05
First Post:
2019-07-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ICU-acquired Colonization and Infection Related to MDR in Immunocompromised Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 759}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-04', 'studyFirstSubmitDate': '2019-07-03', 'studyFirstSubmitQcDate': '2019-08-01', 'lastUpdatePostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Density rate of ICU-acquired infections related to MDR in immunosuppressed patients.', 'timeFrame': 'From ICU admission until day 28 after ICU admission', 'description': 'the number ICU-acquired infections related to MDR will be devided by the number of days in the ICU and reported for 1000 days.'}], 'secondaryOutcomes': [{'measure': 'Density rate of ICU-acquired colonizations related to MDR in immunosuppressed patients', 'timeFrame': 'From ICU admission until day 28 after ICU admission', 'description': 'the number of ICU-acquired colonizations related to MDR will be devided by the number of days in the ICU and reported for 1000 days'}, {'measure': 'Rate of ICU-acquired colonizations related to MDR in immunosuppressed patients.', 'timeFrame': 'From ICU admission until day 28 after ICU admission', 'description': 'The rate of patients with at least one ICU-acquired colonization related to MDR'}, {'measure': 'Rate of ICU-acquired infections related to MDR in immunosuppressed patients', 'timeFrame': 'From ICU admission until day 28 after ICU admission', 'description': 'The rate of patients with at least one ICU-acquired infection related to MDR'}, {'measure': '28 day mortality', 'timeFrame': 'from ICU admission until day 28 after admission', 'description': 'death in the ICU or after discharge from the ICU'}, {'measure': 'Mechanical ventilation duration', 'timeFrame': 'From ICU admission until day 28 after ICU admission', 'description': 'the number of days Under mechanical ventilation'}, {'measure': 'length of stay in intensive care unit', 'timeFrame': 'From ICU admission until day 28 after ICU admission', 'description': 'the number of days of hospitalization in teh ICU'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunocompromised Host', 'Critical care', 'Drug Resistance, Multiple'], 'conditions': ['Immunocompromised Host', 'Critical Care']}, 'descriptionModule': {'briefSummary': 'the number of immunocompromised patients hospitalized in the intensive care units (ICU) is increasing. They are at higher risk of colonization and/or infection with multi-resistant bacteria (MDR). However this risk is not well characterized. ICU acquired infections related to MDR are associated with increased morbidity and mortality. The aim of this study is to compare the incidence of ICU-acquired colonization and ICU-acquired infection related to MDR between immunocompromized and immunocompetent patients. The risk factors for ICU-acquired colonization and ICU-acquired infections, and their impact on outcome will also be evaluated and compared between immunocompromised and immunocompetent patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'immunocompetent patients, and immunocompromised patients admitted to intensive care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Expected ICU stay \\> 48 hours\n* All patients (immunocompromised or immunocompetent).\n\nExclusion Criteria:\n\n* Patients aged \\< 18 years\n* Refusal to take part in the study\n* ICU-stay \\< 48 hours\n* Non availability of initial MDR or subsequent screening\n* Participation in another study that could interfere with the risk of ICU-acquired colonization and infection with MDR bacteria'}, 'identificationModule': {'nctId': 'NCT04043793', 'acronym': 'CIMDREA', 'briefTitle': 'ICU-acquired Colonization and Infection Related to MDR in Immunocompromised Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Intensive Care Unit (ICU)-Acquired Colonization and Infection Related to Multidrug Resistant Bacteria (MDR) in Immunocompromised Patients', 'orgStudyIdInfo': {'id': '2018_07'}, 'secondaryIdInfos': [{'id': '2018-A02756-49', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'country': 'France', 'facility': 'Chu Amiens Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Béthune', 'country': 'France', 'facility': 'Ch Bethune', 'geoPoint': {'lat': 50.52965, 'lon': 2.64003}}, {'city': 'Jossigny', 'country': 'France', 'facility': "Grand Hopital de L'Est Francilien", 'geoPoint': {'lat': 48.83765, 'lon': 2.75432}}, {'city': 'Lens', 'country': 'France', 'facility': 'CH LENS', 'geoPoint': {'lat': 50.43302, 'lon': 2.82791}}, {'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Roger Salengro, CHU', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Roubaix', 'country': 'France', 'facility': 'C.H de Roubaix', 'geoPoint': {'lat': 50.69421, 'lon': 3.17456}}], 'overallOfficials': [{'name': 'Saad NSEIR, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}