NCT03578835

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 6, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

July 6, 2018

Status Verified

July 1, 2018

Enrollment Period

1.9 years

First QC Date

April 11, 2018

Last Update Submit

July 4, 2018

Conditions

Bloodstream InfectionSeptic Shock

Keywords

BSISF-36Clinical OutcomeWhole Genome SequencingPredictive ScoreBloodstream InfectionSeptic ShockMulti-resistant Bacteria

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Multi-center BSI cohort

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Universitätsklinikum Tübingen

Tübingen, Bade-Württemberg, 72076, Germany

RECRUITING

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

RECRUITING

Justus-Liebig-Universität Gießen

Giessen, Hesse, 35392, Germany

RECRUITING

Universitätskliniken Köln

Cologne, North Rhine-Westphalia, 50931, Germany

RECRUITING

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

RECRUITING

Charité - Universitätsmedizin Berlin

Berlin, 12203, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Bacterial strains isolated from blood cultures and samples derived thereof (such as purified DNA).

MeSH Terms

Conditions

SepsisShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Central Study Contacts

Evelina Tacconelli, Prof.

CONTACT

004970712983685Evelina.Tacconelli@med.uni-tuebingen.de

Winfried Kern, Prof.

CONTACT

004976127018190winfried.kern@uniklinik-freiburg.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Infectious Diseases, FESCMID,ESCMID Education Officer,EUCIC Chair

Study Record Dates

First Submitted

April 11, 2018

First Posted

July 6, 2018

Study Start

February 1, 2017

Primary Completion

December 31, 2018

Study Completion

June 30, 2019

Last Updated

July 6, 2018

Record last verified: 2018-07

Locations

DE(6)