Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT04304456
Status:
UNKNOWN
Last Update Posted:
2020-03-11
First Post:
2020-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Epidemiology and Determinants of Outcomes of Hospital Acquired Blood Stream Infections in the Intensive Care in Turkey
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016470', 'term': 'Bacteremia'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'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': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 810}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-10', 'studyFirstSubmitDate': '2020-03-08', 'studyFirstSubmitQcDate': '2020-03-10', 'lastUpdatePostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality Rate', 'timeFrame': '28-day mortality', 'description': 'Rate of all cause mortality'}], 'secondaryOutcomes': [{'measure': 'Progress of organ failures', 'timeFrame': '7-day', 'description': 'Assessed by the components of the Sequential Organ Failure Assessment (SOFA) score, minimum (0 point)- Maximum (24 points)'}, {'measure': 'Days free or organ supportive therapy', 'timeFrame': '28-day', 'description': 'Days free of renal replacement therapy, mechanical ventilation, vasopressors, intensive care unit'}, {'measure': 'Rate of Clinical cure', 'timeFrame': '7-day and 28-day', 'description': 'As evaluated by the treating clinician. There will be no specific tool for evaluation of clinical cure. It will be only determined by the clinical assessment of admitting physicians.'}, {'measure': 'Rate of Microbiological cure', 'timeFrame': '7-day and 28-day', 'description': 'Presence of persisting or relapsing blood stream infection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bacteremia', 'Antimicrobial resistance', 'Mortality', 'Hospital acquired infections'], 'conditions': ['Bacteremia', 'Sepsis', 'Hospital Acquired Condition']}, 'referencesModule': {'references': [{'pmid': '26903338', 'type': 'BACKGROUND', 'citation': 'Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.'}, {'pmid': '19952319', 'type': 'BACKGROUND', 'citation': 'Vincent JL, Rello J, Marshall J, Silva E, Anzueto A, Martin CD, Moreno R, Lipman J, Gomersall C, Sakr Y, Reinhart K; EPIC II Group of Investigators. International study of the prevalence and outcomes of infection in intensive care units. JAMA. 2009 Dec 2;302(21):2323-9. doi: 10.1001/jama.2009.1754.'}, {'pmid': '23011531', 'type': 'BACKGROUND', 'citation': 'Tabah A, Koulenti D, Laupland K, Misset B, Valles J, Bruzzi de Carvalho F, Paiva JA, Cakar N, Ma X, Eggimann P, Antonelli M, Bonten MJ, Csomos A, Krueger WA, Mikstacki A, Lipman J, Depuydt P, Vesin A, Garrouste-Orgeas M, Zahar JR, Blot S, Carlet J, Brun-Buisson C, Martin C, Rello J, Dimopoulos G, Timsit JF. Characteristics and determinants of outcome of hospital-acquired bloodstream infections in intensive care units: the EUROBACT International Cohort Study. Intensive Care Med. 2012 Dec;38(12):1930-45. doi: 10.1007/s00134-012-2695-9. Epub 2012 Sep 26.'}, {'pmid': '29288367', 'type': 'BACKGROUND', 'citation': 'De Waele JJ, Akova M, Antonelli M, Canton R, Carlet J, De Backer D, Dimopoulos G, Garnacho-Montero J, Kesecioglu J, Lipman J, Mer M, Paiva JA, Poljak M, Roberts JA, Rodriguez Bano J, Timsit JF, Zahar JR, Bassetti M. Antimicrobial resistance and antibiotic stewardship programs in the ICU: insistence and persistence in the fight against resistance. A position statement from ESICM/ESCMID/WAAAR round table on multi-drug resistance. Intensive Care Med. 2018 Feb;44(2):189-196. doi: 10.1007/s00134-017-5036-1. Epub 2017 Dec 29.'}, {'pmid': '28320242', 'type': 'BACKGROUND', 'citation': 'PRISM Investigators; Rowan KM, Angus DC, Bailey M, Barnato AE, Bellomo R, Canter RR, Coats TJ, Delaney A, Gimbel E, Grieve RD, Harrison DA, Higgins AM, Howe B, Huang DT, Kellum JA, Mouncey PR, Music E, Peake SL, Pike F, Reade MC, Sadique MZ, Singer M, Yealy DM. Early, Goal-Directed Therapy for Septic Shock - A Patient-Level Meta-Analysis. N Engl J Med. 2017 Jun 8;376(23):2223-2234. doi: 10.1056/NEJMoa1701380. Epub 2017 Mar 21.'}]}, 'descriptionModule': {'briefSummary': 'In this observational study, it is aimed to investigate the mortality and morbidity rates of hospital-acquired blood stream infections that are treated in intensive care units (ICU). The effects of properties of the micro-organism such as type and antimicrobial resistance on the infection and its outcomes will be mainly explored. In addition, the impact of antibiotic options and other treatment modalities on survival of patients will be investigated. Twenty-seven different ICUs from Turkey will be included in this study.', 'detailedDescription': "Blood stream infection (BSI) is defined as the identification of a culprit pathogen in the blood culture sample of a participant. As such, and once contaminants are excluded, BSI is the only cause of sepsis where the presence of an infection and the pathogen are known with certainty. This makes BSI the perfect model of infection to study the effects of the micro-organism on the participant, and the effects of the antibiotics and other treatments on survival. There is an increasing trend in antimicrobial resistance rates among microorganisms that are associated with nosocomial infections treated in ICU. However, infectious diseases physicians from Turkey do not know contemporary epidemiological data of hospital-acquired BSI treated in ICU in Turkey.\n\nThis study 'Epidemiology and Determinants of Outcomes of Hospital-Acquired Blood Stream Infections in the Intensive Care in Turkey' is a multi-center prospective observational cohort study that will include patients with hospital-acquired blood stream infections (HA-BSI) treated in ICUs in Turkey. This study will present unknown current epidemiology of HA-BSI in Turkey. Furthermore, It will provide very important data about 28-day mortality rates of HA-BSI treated in ICU. The primary outcomes of this study can be accounted as following: (i)determinants of outcomes of HA-BSI, (ii) the effects of the source of infection on outcomes, (iii) the effects of microorganism on these outcomes, (iv) the effects of antimicrobial therapy and of source control on investigated outcomes. In this study, participant specific and organizational factors will be explored and the determinants of management of HA-BSI in ICUs will be described.\n\nThere will be no intervention in this study. The data of participants will be obtained from hospital database and recorded into electronic case report forms anonymously."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a HA-BSI treated in an ICU', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 Years.\n* Hospital Acquired Bloodstream Infection (HA-BSI).\n* Treated in the ICU.\n* ICU acquired OR Hospital acquired prior to ICU admission\n\nExclusion Criteria:\n\n* Patients that had a positive blood culture in the hospital and transferred to ICU for a different reason than specific treatment of the causes or consequences of HA-BSI.\n* Previous inclusion in the study.\n* HA-BSI is defined as a positive blood culture (BC) sampled after 48 hours following hospital admission.'}, 'identificationModule': {'nctId': 'NCT04304456', 'briefTitle': 'Epidemiology and Determinants of Outcomes of Hospital Acquired Blood Stream Infections in the Intensive Care in Turkey', 'organization': {'class': 'OTHER', 'fullName': 'SCARE (Study group for carbapenem resistance)'}, 'officialTitle': 'Epidemiology and Determinants of Outcomes of Hospital Acquired Blood Stream Infections in the Intensive Care in Turkey', 'orgStudyIdInfo': {'id': 'KA-19126'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HA-BSI', 'description': 'Patients with HA-BSI treated in an ICU', 'interventionNames': ['Other: Treatment']}], 'interventions': [{'name': 'Treatment', 'type': 'OTHER', 'description': 'Antimicrobial and other treatment modalities such as source control, vasoactive medications, dialysis', 'armGroupLabels': ['HA-BSI']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Abdullah Tarık Aslan', 'role': 'CONTACT', 'email': 'aslanabdullahtarik@gmail.com', 'phone': '+905346754889'}, {'name': 'Murat Akova', 'role': 'CONTACT', 'email': 'akova.murat@gmail.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SCARE (Study group for carbapenem resistance)', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Society of Intensive Care Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}