Bloodstream Infection Due to Multidrug-Resistant Organisms - Multicenter Study on Determinants of Clinical Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 6,000
- Locations
- 6
- Primary Endpoint
- Long-term mortality due to bloodstream infection
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
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.
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Prof. Dr. Evelina Tacconelli
Prof. Infectious Diseases, FESCMID,ESCMID Education Officer,EUCIC Chair
University Hospital Tuebingen