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

• Conditions: Septic Shock; Bloodstream Infection

• Registration Number: NCT03578835
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2018-04-11
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-04
• Last Update Submitted: 2018-07-04
• Study First Posted: 2018-07-06
• Last Update Posted: 2018-07-06
• Primary Completion: 2018-12-31
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (6)

Universitätskliniken Köln; 🇩🇪 Köln, Nordrhein-Westfalen, Germany

Universitätsklinikum Schleswig-Holstein; 🇩🇪 Lübeck, Schleswig-Holstein, Germany

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Universitätsklinikum Tübingen; 🇩🇪 Tübingen, Bade-Württemberg, Germany

Justus-Liebig-Universität Gießen; 🇩🇪 Gießen, Hessen, Germany

Universitätsklinikum Freiburg; 🇩🇪 Freiburg, Baden-Württemberg, Germany