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

Study Overview
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Brief Summary
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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.

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

Conditions
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Bloodstream Infection, Septic Shock

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multi-center BSI cohort<br>Patients from six German study centers suffering from bloodstream infection caused by specific target organisms. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BSI, SF-36, Clinical Outcome, Whole Genome Sequencing, Predictive Score, Bloodstream Infection, Septic Shock, Multi-resistant Bacteria