Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-29 @ 4:30 PM
Study NCT ID:
NCT06392568
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiological Features of Emergent Highly Resistant Bacteria in Tunisian Intensive Care Units
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-27', 'studyFirstSubmitDate': '2024-03-30', 'studyFirstSubmitQcDate': '2024-04-27', 'lastUpdatePostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Highly resistant bacterial healthcare associated infections', 'timeFrame': '2 months', 'description': 'Incidence of eHRB healthcare associated infections in ICU'}, {'measure': 'Epidemiological features of Highly resistant bacterial healthcare associated infections healthcare associated infections in ICU', 'timeFrame': '2 months', 'description': 'Causative micro-organisms, sites and risk factors of eHRB healthcare associated infections in ICU'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Critical care', 'Healthcare Associated Infections', 'Drug resistance'], 'conditions': ['Cross Infection', 'Carbapenem Resistant Bacterial Infection', 'Vancomycin-Resistant Enterococcal Infection', 'Critical Illness']}, 'descriptionModule': {'briefSummary': 'Investigate the epidemiology, risk factors and impact on clinical practice of healthcare-associated infections with emergent highly drug-resistant (eHDR) pathogens, particularly carbapenem resistant enterobacteriaceae and glycopeptides-resistant enterococcus.', 'detailedDescription': "In 2022, a previous one-day point-prevalence multicenter study (NOSOREA2, NCT05547646) showed that most prevalent pathogens causing healthcare-associated infections were carbapenem resistant enterobacteriaceae. In 2017, (NOSOREA1, LA TUNISIE MEDICALE - 2018 ; Vol 96 (10/11)), most prevalent pathogens were non-fermenting pathogens.\n\nFaced with this major epidemiological change within Tunisian ICUs, we decided to launch a 3rd survey under the aegis of the 'Association tunisienne de réanimation'. We aimed to investigate the epidemiology, risk factors and impact on clinical practice of healthcare-associated infections with emergent highly drug-resistant (eHDR) pathogens, particularly carbapenem resistant enterobacteriaceae and glycopeptides-resistant enterococcus. So we conducted a multicenter prospective collection that will take place over 2 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult ICU patients admitted during the study period', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult ICU patients admitted during the study period\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT06392568', 'acronym': 'NOSOREA3', 'briefTitle': 'Epidemiological Features of Emergent Highly Resistant Bacteria in Tunisian Intensive Care Units', 'organization': {'class': 'OTHER', 'fullName': 'Abderrahmane Mami Hospital'}, 'officialTitle': 'Epidemiological Features of Emergent Highly Resistant Bacteria in Tunisian Intensive Care Units: A Prospective Multicenter National Observational Study (NOSOREA-3)', 'orgStudyIdInfo': {'id': 'ATR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'eHDR+', 'description': 'Patients with Emergent Highly Resistant Bacteria healthcare associated infection', 'interventionNames': ['Other: epidemiological records']}, {'label': 'eHDR-', 'description': 'Patients without Emergent Highly Resistant Bacteria healthcare associated infection'}], 'interventions': [{'name': 'epidemiological records', 'type': 'OTHER', 'description': 'Healthcare associated infections due to emergent highly resistant bacteria, sites, risk factors, treatment and outcome', 'armGroupLabels': ['eHDR+']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2080', 'city': 'Ariana', 'state': 'Tunis Governorate', 'status': 'RECRUITING', 'country': 'Tunisia', 'contacts': [{'name': 'JAMOUSSI Amira, Pr', 'role': 'CONTACT', 'email': 'amira.jamoussi@fmt.utm.tn', 'phone': '+21698375250'}, {'name': 'Asma MAHDI, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Inès SEDGHIANI, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Inès FATHALLAH, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hassen BEN GHEZALA, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lilya DEBBICHE, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Khaoula BEN ISMAIL, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hend ALLOUCHE, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Radhouane TOUMI, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sana KHARRAT, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fatma KAANICHE, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hager NOUIRA, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Manel LAHMER, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Abderrahmen Mami'}], 'centralContacts': [{'name': 'Amira JAMOUSSI, Professor', 'role': 'CONTACT', 'email': 'amira.jamoussi@fmt.utm.tn', 'phone': '+21698375250'}, {'name': 'Jalila BEN KHELIL, Professor', 'role': 'CONTACT', 'email': 'jalila.benkhelil@fmt.utm.tn', 'phone': '+21653689799'}], 'overallOfficials': [{'name': 'Amira JAMOUSSI, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abderrahmen Mami Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abderrahmane Mami Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Amira JAMOUSSI', 'investigatorAffiliation': 'Abderrahmane Mami Hospital'}}}}