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

NCT ID: NCT03578835

Last Updated: 2018-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-01

Study Completion Date

2019-06-30

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.

Detailed Description

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Conditions

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Bloodstream Infection Septic Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Multi-center BSI cohort

Patients from six German study centers suffering from bloodstream infection caused by specific target organisms.

No interventions assigned to this group

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Freiburg

OTHER

Sponsor Role collaborator

University Hospital Lübeck

OTHER

Sponsor Role collaborator

University Hospital of Berlin

OTHER

Sponsor Role collaborator

University of Giessen

OTHER

Sponsor Role collaborator

Universitätsklinikum Köln

OTHER

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Evelina Tacconelli

Prof. Infectious Diseases, FESCMID,ESCMID Education Officer,EUCIC Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universitätsklinikum Tübingen

Tübingen, Bade-Württemberg, Germany

Site Status RECRUITING

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status RECRUITING

Justus-Liebig-Universität Gießen

Giessen, Hesse, Germany

Site Status RECRUITING

Universitätskliniken Köln

Cologne, North Rhine-Westphalia, Germany

Site Status RECRUITING

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, Germany

Site Status RECRUITING

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Evelina Tacconelli, Prof.

Role: CONTACT

004970712983685

Winfried Kern, Prof.

Role: CONTACT

004976127018190

Other Identifiers

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DZIF TTU 08.810

Identifier Type: -

Identifier Source: org_study_id

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