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

Septic Shock Clinical Trial

— BLOOMY-COM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03578835
• Other study ID #: DZIF TTU 08.810
• Status: Recruiting
• Start date: February 1, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2018
• Source: University Hospital Tuebingen
• Contact: Evelina Tacconelli, Prof.
• Phone: 004970712983685
• Email: Evelina.Tacconelli[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: June 30, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bloodstream Infection
• Communicable Diseases
• Infection
• Septic Shock
• Shock, Septic

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Universitätsklinikum Freiburg	Freiburg	Baden-Württemberg
Germany	Justus-Liebig-Universität Gießen	Gießen	Hessen
Germany	Universitätskliniken Köln	Köln	Nordrhein-Westfalen
Germany	Universitätsklinikum Schleswig-Holstein	Lübeck	Schleswig-Holstein
Germany	Universitätsklinikum Tübingen	Tübingen	Bade-Württemberg

Sponsors (6)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Universitätsklinikum Köln, University Hospital Freiburg, University Hospital Lübeck, University Hospital of Berlin, University of Giessen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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