Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:15 PM
Study NCT ID:
NCT03578835
Status:
UNKNOWN
Last Update Posted:
2018-07-06
First Post:
2018-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bloodstream Infection Due to Multidrug-Resistant Organisms - Multicenter Study on Determinants of Clinical Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'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': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Bacterial strains isolated from blood cultures and samples derived thereof (such as purified DNA).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6000}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-04', 'studyFirstSubmitDate': '2018-04-11', 'studyFirstSubmitQcDate': '2018-07-04', 'lastUpdatePostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short-term mortality due to bloodstream infection', 'timeFrame': 'From index blood culture to discharge, an average of 16 days', 'description': 'Mortality due to bloodstream infection up to hospital discharge in association to causative species, resistance pattern, comorbidities, complications etc.'}, {'measure': 'Long-term mortality due to bloodstream infection', 'timeFrame': 'Up to 6 months', 'description': 'Mortality due to bloodstream infection up to long-term follow-up after 6 months in association to causative species, resistance pattern, comorbidities, complications etc.'}, {'measure': 'Long-term morbidity due to bloodstream infection', 'timeFrame': 'At 6 months', 'description': 'Morbidity as measured by the SF-36 questionnaire due to bloodstream infection after 6 months in association to causative species, resistance pattern, comorbidities, complications etc.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BSI', 'SF-36', 'Clinical Outcome', 'Whole Genome Sequencing', 'Predictive Score', 'Bloodstream Infection', 'Septic Shock', 'Multi-resistant Bacteria'], 'conditions': ['Bloodstream Infection', 'Septic Shock']}, 'descriptionModule': {'briefSummary': 'Continual surveillance of both community-acquired and nosocomial bloodstream infections for specific target organisms. Analysis of comorbidities, complications, bacterial resistance patterns, bacterial genomics (e. g. via WGS and MLST typing) for the determinants of clinical outcomes. The clinical outcomes are investigated both in the short-term (up until discharge) and the long-term (six months after index blood culture by standardized questionnaire). A predictive point-of-care score is to be developed based on these data to define high-risk patient populations requiring more intensive diagnostic and/or treatment regimens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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 given either by patient or guardian\n* Inpatient\n* At least one blood culture positive for one of the following bacteria: Staphylococcus aureus, Enterococcus spp., Escherichia coli, Enterobacter spp., Klebsiella spp., Acinetobacter baumannii, Pseudomonas aeruginosa\n\nExclusion Criteria:\n\n* Less than 18 years old\n* Not capable of giving informed consent nor informed consent given by guardian\n* Outpatient\n* No blood cultures positive for any of the target organisms'}, 'identificationModule': {'nctId': 'NCT03578835', 'acronym': 'BLOOMY-COM', 'briefTitle': 'Bloodstream Infection Due to Multidrug-Resistant Organisms - Multicenter Study on Determinants of Clinical Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Bloodstream Infection Due to Multidrug-Resistant Organisms - Multicenter Study on Determinants of Clinical Outcomes', 'orgStudyIdInfo': {'id': 'DZIF TTU 08.810'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Multi-center BSI cohort', 'description': 'Patients from six German study centers suffering from bloodstream infection caused by specific target organisms.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'state': 'Bade-Württemberg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Universitätsklinikum Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Universitätsklinikum Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '35392', 'city': 'Giessen', 'state': 'Hesse', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Justus-Liebig-Universität Gießen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '50931', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Universitätskliniken Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '23538', 'city': 'Lübeck', 'state': 'Schleswig-Holstein', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Universitätsklinikum Schleswig-Holstein', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '12203', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Evelina Tacconelli, Prof.', 'role': 'CONTACT', 'email': 'Evelina.Tacconelli@med.uni-tuebingen.de', 'phone': '004970712983685'}, {'name': 'Winfried Kern, Prof.', 'role': 'CONTACT', 'email': 'winfried.kern@uniklinik-freiburg.de', 'phone': '004976127018190'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital Freiburg', 'class': 'OTHER'}, {'name': 'University Hospital Lübeck', 'class': 'OTHER'}, {'name': 'University Hospital of Berlin', 'class': 'OTHER'}, {'name': 'University of Giessen', 'class': 'OTHER'}, {'name': 'Universitätsklinikum Köln', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Infectious Diseases, FESCMID,ESCMID Education Officer,EUCIC Chair', 'investigatorFullName': 'Prof. Dr. Evelina Tacconelli', 'investigatorAffiliation': 'University Hospital Tuebingen'}}}}