Clinical trial NCT03578835: Bloodstream Infection Due to Multidrug-Resistant Organisms - Multicenter Study on Determinants of Clinical Outcomes
Official title: Bloodstream Infection Due to Multidrug-Resistant Organisms - Multicenter Study on Determinants of Clinical Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bloodstream Infection
Septic Shock
Keywords: BSI
SF-36
Clinical Outcome
Whole Genome Sequencing
Predictive Score
Bloodstream Infection
Septic Shock
Multi-resistant Bacteria
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: University Hospital Freiburg
name: University Hospital Lübeck
name: University Hospital of Berlin
name: University of Giessen
name: Universitätsklinikum Köln
First posted: 2018-07-06
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Short-term mortality due to bloodstream infection
timeFrame: From index blood culture to discharge, an average of 16 days
measure: Long-term mortality due to bloodstream infection
timeFrame: Up to 6 months
measure: Long-term morbidity due to bloodstream infection
timeFrame: At 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
state: Bade-Württemberg
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
state: Baden-Württemberg
city: Gießen
country: Germany
facility: Justus-Liebig-Universität Gießen
state: Hessen
city: Köln
country: Germany
facility: Universitätskliniken Köln
state: Nordrhein-Westfalen
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
References: