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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03578835

Acronym

BLOOMY-COM

Enrollment

6000

Registered

2018-07-06

Start date

2017-02-01

Completion date

2019-06-30

Last updated

2018-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bloodstream Infection, Septic Shock

Keywords

BSI, SF-36, Clinical Outcome, Whole Genome Sequencing, Predictive Score, Bloodstream Infection, Septic Shock, Multi-resistant Bacteria

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Long-term morbidity due to bloodstream infection	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.
Short-term mortality due to bloodstream infection	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 mortality due to bloodstream infection	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.

Countries

Germany

Contacts

Primary ContactEvelina Tacconelli, Prof.

Evelina.Tacconelli@med.uni-tuebingen.de004970712983685

Backup ContactWinfried Kern, Prof.

winfried.kern@uniklinik-freiburg.de004976127018190

Outcome results