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

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ClinicalTrials.gov Identifier: NCT03578835
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : July 6, 2018
Sponsor:
Collaborators:
University Hospital Freiburg
University Hospital Lübeck
University Hospital of Berlin
University of Giessen
Universitätsklinikum Köln
Information provided by (Responsible Party):
Prof. Dr. Evelina Tacconelli, University Hospital Tuebingen

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
Bloodstream Infection Septic Shock

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Bloodstream Infection Due to Multidrug-Resistant Organisms - Multicenter Study on Determinants of Clinical Outcomes
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : June 30, 2019

Group/Cohort
Multi-center BSI cohort
Patients from six German study centers suffering from bloodstream infection caused by specific target organisms.



Primary Outcome Measures :
  1. Short-term mortality due to bloodstream infection [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Bacterial strains isolated from blood cultures and samples derived thereof (such as purified DNA).


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03578835


Contacts
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Contact: Evelina Tacconelli, Prof. 004970712983685 Evelina.Tacconelli@med.uni-tuebingen.de
Contact: Winfried Kern, Prof. 004976127018190 winfried.kern@uniklinik-freiburg.de

Locations
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Germany
Universitätsklinikum Tübingen Recruiting
Tübingen, Bade-Württemberg, Germany, 72076
Universitätsklinikum Freiburg Recruiting
Freiburg, Baden-Württemberg, Germany, 79106
Justus-Liebig-Universität Gießen Recruiting
Gießen, Hessen, Germany, 35392
Universitätskliniken Köln Recruiting
Köln, Nordrhein-Westfalen, Germany, 50931
Universitätsklinikum Schleswig-Holstein Recruiting
Lübeck, Schleswig-Holstein, Germany, 23538
Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 12203
Sponsors and Collaborators
University Hospital Tuebingen
University Hospital Freiburg
University Hospital Lübeck
University Hospital of Berlin
University of Giessen
Universitätsklinikum Köln

Additional Information:

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Responsible Party: Prof. Dr. Evelina Tacconelli, Prof. Infectious Diseases, FESCMID,ESCMID Education Officer,EUCIC Chair, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03578835     History of Changes
Other Study ID Numbers: DZIF TTU 08.810
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018

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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, University Hospital Tuebingen:
BSI
SF-36
Clinical Outcome
Whole Genome Sequencing
Predictive Score
Bloodstream Infection
Septic Shock
Multi-resistant Bacteria

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Shock, Septic
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock