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BLOOMY-COM: Bloodstream Infection Due to Multidrug-Resistant Organisms - Multicenter Study on Determinants of Clinical Outcomes

Sponsor
University Hospital Tuebingen (Other)
Overall Status
Unknown status
CT.gov ID
NCT03578835
Collaborator
University Hospital Freiburg (Other), University Hospital Lübeck (Other), University Hospital of Berlin (Other), University of Giessen (Other), Universitätsklinikum Köln (Other)
6,000
Enrollment
6
Locations
28.9
Anticipated Duration (Months)
1000
Patients Per Site
34.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    6000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Bloodstream Infection Due to Multidrug-Resistant Organisms - Multicenter Study on Determinants of Clinical Outcomes
    Actual Study Start Date :
    Feb 1, 2017
    Anticipated Primary Completion Date :
    Dec 31, 2018
    Anticipated Study Completion Date :
    Jun 30, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Multi-center BSI cohort

    Patients from six German study centers suffering from bloodstream infection caused by specific target organisms.

    Outcome Measures

    Primary Outcome Measures

    1. Short-term mortality due to bloodstream infection [From index blood culture to discharge, an average of 16 days]

      Mortality due to bloodstream infection up to hospital discharge in association to causative species, resistance pattern, comorbidities, complications etc.

    2. Long-term mortality due to bloodstream infection [Up to 6 months]

      Mortality due to bloodstream infection up to long-term follow-up after 6 months in association to causative species, resistance pattern, comorbidities, complications etc.

    3. Long-term morbidity due to bloodstream infection [At 6 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • At least 18 years old

    • Informed consent given either by patient or guardian

    • Inpatient

    • 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

    Exclusion Criteria:

    • Less than 18 years old

    • Not capable of giving informed consent nor informed consent given by guardian

    • Outpatient

    • No blood cultures positive for any of the target organisms

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universitätsklinikum Tübingen Tübingen Bade-Württemberg Germany 72076
    2 Universitätsklinikum Freiburg Freiburg Baden-Württemberg Germany 79106
    3 Justus-Liebig-Universität Gießen Gießen Hessen Germany 35392
    4 Universitätskliniken Köln Köln Nordrhein-Westfalen Germany 50931
    5 Universitätsklinikum Schleswig-Holstein Lübeck Schleswig-Holstein Germany 23538
    6 Charité - Universitätsmedizin Berlin Berlin Germany 12203

    Sponsors and Collaborators

    • University Hospital Tuebingen
    • University Hospital Freiburg
    • University Hospital Lübeck
    • University Hospital of Berlin
    • University of Giessen
    • Universitätsklinikum Köln

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof. Dr. Evelina Tacconelli, Prof. Infectious Diseases, FESCMID,ESCMID Education Officer,EUCIC Chair, University Hospital Tuebingen
    ClinicalTrials.gov Identifier:
    NCT03578835
    Other Study ID Numbers:
    • DZIF TTU 08.810
    First Posted:
    Jul 6, 2018
    Last Update Posted:
    Jul 6, 2018
    Last Verified:
    Jul 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Prof. Dr. Evelina Tacconelli, Prof. Infectious Diseases, FESCMID,ESCMID Education Officer,EUCIC Chair, University Hospital Tuebingen
    BSI
    SF-36
    Clinical Outcome
    Whole Genome Sequencing
    Predictive Score
    Bloodstream Infection
    Septic Shock
    Multi-resistant Bacteria
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Shock, Septic
    Sepsis

    Study Results

    No Results Posted as of Jul 6, 2018