Ignite Creation Date:
2025-12-24 @ 12:23 PM
Ignite Modification Date:
2025-12-27 @ 9:53 PM
Study NCT ID:
NCT04937361
Status:
UNKNOWN
Last Update Posted:
2023-11-29
First Post:
2021-06-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring of MDRO Dynamics and Resistance Mechanisms in a University Hospital Network
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Bacterial strains isolated from rectal swabs, blood cultures and samples derived thereof (such as purified DNA)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12000}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2021-06-10', 'studyFirstSubmitQcDate': '2021-06-22', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'monitoring of MDRO prevalence', 'timeFrame': 'at hospital admission', 'description': 'obtain a better understanding for the emergence of resistance within the microenvironment under selective pressure'}, {'measure': 'monitoring of blood stream infections', 'timeFrame': 'during hospitalization, up to 4 weeks', 'description': 'obtain a better understanding for the emergence of resistance within the microenvironment under selective pressure'}, {'measure': 'integrate novel techniques for microbiome-resistome interaction analysis', 'timeFrame': 'through study completion, after 4 years', 'description': 'obtain a better understanding for the emergence of resistance within the microenvironment under selective pressure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['MDRO']}, 'descriptionModule': {'briefSummary': 'Survey on the prevalence of MDRO to monitor the import of MDRO from the community. Rectal swabs will be taken and cultivated. Survey on community-onset and nosocomial bloodstream infections will be documented and strains will be isolated. For each BSI a clinical data set will be obtained (e.g. patient age, gender, date of hospitalization, antibiotic therapy). Genetic analysis of MDRO from the prevalence and BSI study. In a subset of patients the microbiome-resistome interactome will be analysed in more detail. Furthermore, the impact of infection control measures due to the Covid-19 pandemic on nosocomial BSI will be investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'For the prevalence, adult patients admitted to the hosptial within the last 3 days.\n\nFor BSI surveillance, adult inpatients with at least one blood culture positive for any of the target organisms: Staphylococcus aureus, Enterococcus spp., Escherichia coli, Enterobacter spp., Klebsiella spp., Acinetobacter baumannii, Pseudomonas aeruginosa.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 18 years old\n* informed consent\n* inpatient\n\nExclusion Criteria:\n\n* less than 18 years old\n* Not capable of giving informed consent\n* outpatient'}, 'identificationModule': {'nctId': 'NCT04937361', 'acronym': 'R-Net', 'briefTitle': 'Monitoring of MDRO Dynamics and Resistance Mechanisms in a University Hospital Network', 'organization': {'class': 'OTHER', 'fullName': 'University of Luebeck'}, 'officialTitle': 'Monitoring of MDRO Dynamics and Resistance Mechanisms in a University Hospital Network', 'orgStudyIdInfo': {'id': 'DZIF TTU 08.824'}}, 'armsInterventionsModule': {'interventions': [{'name': 'rectal swab', 'type': 'OTHER', 'description': 'collection of rectal swabs'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lübeck', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Nadja Käding', 'role': 'CONTACT', 'email': 'nadja.kaeding@uksh.de', 'phone': '+4945131019010'}], 'facility': 'Klinik für Infektiologie und Mikrobiologie', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Luebeck', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital of Berlin', 'class': 'OTHER'}, {'name': 'University Hospital of Cologne', 'class': 'OTHER'}, {'name': 'University Hospital Freiburg', 'class': 'OTHER'}, {'name': 'University of Giessen', 'class': 'OTHER'}, {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med.', 'investigatorFullName': 'Nadja Käding', 'investigatorAffiliation': 'University of Luebeck'}}}}