Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-01 @ 8:55 AM
Study NCT ID:
NCT04926935
Status:
COMPLETED
Last Update Posted:
2021-06-15
First Post:
2021-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bloodstram Infections in ICU. Single Centre Observational Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3502}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-08', 'studyFirstSubmitDate': '2021-06-04', 'studyFirstSubmitQcDate': '2021-06-08', 'lastUpdatePostDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Results of microbiological analysis.', 'timeFrame': 'After completion of the microbiological analysis, up to 72 hours.', 'description': 'Results of the microbiological analysis of the blood samples collected from patients with clinically suspected infections hospitalized in the ICU during the study period.'}, {'measure': "Isolated pathogens' susceptibility for antimicrobial agents. .", 'timeFrame': 'After completion of the microbiological analysis, up to 72 hours.', 'description': 'Results of the microbiological analysis of the blood samples collected from patients with clinically suspected infections hospitalized in the ICU during the study period.'}, {'measure': "Isolated pathogens' resistance for antimicrobial agents. .", 'timeFrame': 'After completion of the microbiological analysis, up to 72 hours.', 'description': 'Results of the microbiological analysis of the blood samples collected from patients with clinically suspected infections hospitalized in the ICU during the study period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bloodstream Infection', 'Antibiotic Resistant Strain', 'Intensive Care Unit']}, 'referencesModule': {'references': [{'pmid': '16575729', 'type': 'RESULT', 'citation': 'Garrouste-Orgeas M, Timsit JF, Tafflet M, Misset B, Zahar JR, Soufir L, Lazard T, Jamali S, Mourvillier B, Cohen Y, De Lassence A, Azoulay E, Cheval C, Descorps-Declere A, Adrie C, Costa de Beauregard MA, Carlet J; OUTCOMEREA Study Group. Excess risk of death from intensive care unit-acquired nosocomial bloodstream infections: a reappraisal. Clin Infect Dis. 2006 Apr 15;42(8):1118-26. doi: 10.1086/500318. Epub 2006 Mar 14.'}, {'pmid': '16621137', 'type': 'RESULT', 'citation': 'Laupland KB, Lee H, Gregson DB, Manns BJ. Cost of intensive care unit-acquired bloodstream infections. J Hosp Infect. 2006 Jun;63(2):124-32. doi: 10.1016/j.jhin.2005.12.016. Epub 2006 Apr 18.'}, {'pmid': '20491834', 'type': 'RESULT', 'citation': 'Wilson J, Elgohari S, Livermore DM, Cookson B, Johnson A, Lamagni T, Chronias A, Sheridan E. Trends among pathogens reported as causing bacteraemia in England, 2004-2008. Clin Microbiol Infect. 2011 Mar;17(3):451-8. doi: 10.1111/j.1469-0691.2010.03262.x.'}, {'pmid': '24576825', 'type': 'RESULT', 'citation': 'Nielsen SL, Pedersen C, Jensen TG, Gradel KO, Kolmos HJ, Lassen AT. Decreasing incidence rates of bacteremia: a 9-year population-based study. J Infect. 2014 Jul;69(1):51-9. doi: 10.1016/j.jinf.2014.01.014. Epub 2014 Feb 25.'}, {'pmid': '23039210', 'type': 'RESULT', 'citation': 'de Kraker ME, Jarlier V, Monen JC, Heuer OE, van de Sande N, Grundmann H. The changing epidemiology of bacteraemias in Europe: trends from the European Antimicrobial Resistance Surveillance System. Clin Microbiol Infect. 2013 Sep;19(9):860-8. doi: 10.1111/1469-0691.12028. Epub 2012 Oct 8.'}, {'pmid': '23473333', 'type': 'RESULT', 'citation': 'Goto M, Al-Hasan MN. Overall burden of bloodstream infection and nosocomial bloodstream infection in North America and Europe. Clin Microbiol Infect. 2013 Jun;19(6):501-9. doi: 10.1111/1469-0691.12195. Epub 2013 Mar 8.'}]}, 'descriptionModule': {'briefSummary': 'Hospital-acquired bloodstream infection (BSI) is serious care problem worldwide associated with significant morbidity and mortality. However, only few nationwide studies have focused on the incidence of BSI, and its results were often inconsistent.\n\nThe objective of this study was to analyze bloodstream infections in patients hospitalized in the intensive care unit of the tertiary, university hospital. Special attention was put on the etiology of the infections, the antimicrobial susceptibility/resistance of the isolated pathogens, as well as the incidence of central vein catheters infections in the analyzed population.\n\nData were collected in the intensive care unit of the Military Institute of Medicine, Warsaw, Poland, between January, 1, 2007 and December, 31, 2019.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients hospitalized in the ICU with clinically suspected infection between 2007-2019.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients hospitalized in the ICU with clinically suspected infection.\n\nExclusion Criteria:\n\n* none.'}, 'identificationModule': {'nctId': 'NCT04926935', 'briefTitle': 'Bloodstram Infections in ICU. Single Centre Observational Study.', 'organization': {'class': 'OTHER', 'fullName': 'Military Institute od Medicine National Research Institute'}, 'officialTitle': 'Bloodstram Infections in Intensive Care Unit. A Single Centre Bacteriological Analysis Between 2007-2019.', 'orgStudyIdInfo': {'id': '09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients hospitalized in the ICU during the study period.', 'description': 'Patients hospitalized in the ICU during the study period with clinically suspected infection.', 'interventionNames': ['Diagnostic Test: Microbiological analysis of blood samples.']}], 'interventions': [{'name': 'Microbiological analysis of blood samples.', 'type': 'DIAGNOSTIC_TEST', 'description': 'Microbiological analysis of blood samples collected from the patients with clinically suspected infection.', 'armGroupLabels': ['Patients hospitalized in the ICU during the study period.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04-141', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Department of Anesthesiology and Intensive Therapy', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Dariusz Tomaszewski, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Military Institute od Medicine National Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Military Institute od Medicine National Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Dariusz Tomaszewski', 'investigatorAffiliation': 'Military Institute od Medicine National Research Institute'}}}}