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

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.

Study Overview

• Status: Unknown
• Conditions: Septic Shock; Bloodstream Infection

• Study Type: Observational
• Enrollment (Anticipated): 6000

Contacts and Locations

• Study Contact: Name: Evelina Tacconelli, Prof.; Phone Number: 004970712983685; Email: Evelina.Tacconelli@med.uni-tuebingen.de
• Study Contact Backup: Name: Winfried Kern, Prof.; Phone Number: 004976127018190; Email: winfried.kern@uniklinik-freiburg.de

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Recruiting
    • Charité - Universitätsmedizin Berlin
  • Bade-Württemberg
    • Tübingen, Bade-Württemberg, Germany, 72076
      • Recruiting
      • Universitätsklinikum Tübingen
  • Baden-Württemberg
    • Freiburg, Baden-Württemberg, Germany, 79106
      • Recruiting
      • Universitätsklinikum Freiburg
  • Hessen
    • Gießen, Hessen, Germany, 35392
      • Recruiting
      • Justus-Liebig-Universität Gießen
  • Nordrhein-Westfalen
    • Köln, Nordrhein-Westfalen, Germany, 50931
      • Recruiting
      • Universitätskliniken Köln
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • Recruiting
      • Universitätsklinikum Schleswig-Holstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-term mortality due to bloodstream infection	Mortality due to bloodstream infection up to hospital discharge in association to causative species, resistance pattern, comorbidities, complications etc.	From index blood culture to discharge, an average of 16 days
Long-term mortality due to bloodstream infection	Mortality due to bloodstream infection up to long-term follow-up after 6 months in association to causative species, resistance pattern, comorbidities, complications etc.	Up to 6 months
Long-term morbidity due to bloodstream infection	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.	At 6 months

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Collaborators: University of Giessen; University Hospital Freiburg; Universitätsklinikum Köln; University Hospital Lübeck; University Hospital of Berlin

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): June 30, 2019

Study Registration Dates

• First Submitted: April 11, 2018
• First Submitted That Met QC Criteria: July 4, 2018
• First Posted (Actual): July 6, 2018

Study Record Updates

• Last Update Posted (Actual): July 6, 2018
• Last Update Submitted That Met QC Criteria: July 4, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Septic Shock; SF-36; BSI; Bloodstream Infection; Clinical Outcome; Whole Genome Sequencing; Predictive Score; Multi-resistant Bacteria
• Additional Relevant MeSH Terms: Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Shock; Sepsis; Infections; Communicable Diseases; Shock, Septic
• Other Study ID Numbers: DZIF TTU 08.810

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No