Prognostic Factors of Escherichia Coli Bloodstream Infections: Severity Score and Therapeutic Implications (SEPTICOLI)
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|ClinicalTrials.gov Identifier: NCT02890901|
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : May 29, 2018
The determinants associated with severe outcome and death from Escherichia coli bloodstream infections (BSI) remain poorly understood. The epidemiology of E. coli BSI has recently changed dramatically with the global emergence of multiresistant strains producing extended-spectrum ß-lactamases (ESBL). Outcome is worse in case of ESBL-E. coli, which may be due to the intrinsic virulence of ESBL-E. coli or to a delayed adequate empirical antibiotic therapy because of multiresistance. Predicting the severity of an infection as soon as the initial clinical assessment is of major importance to provide the best care, while limiting unnecessary hospitalizations and costs. Yet, no simple clinical score exists to predict the severity of E. coli infections.
In a translational approach, the investigators will include during a maximum of one year 500 adults with E. coli BSI hospitalized in 7 hospitals in the Paris area, France. Precise clinical data will be collected at inclusion and 28 days after inclusion or upon patient's discharge (if before day 28). The primary endpoint of the study is death from E. coli BSI at day 28.
The first aim is to determine risk-factors for death at day 28, including clinical and bacteriological factors (determined by WGS) in the era of the global emergence of ESBL producing E. coli. The second aim is to determine virulence characteristics of ESBL strains both at the genome and phenotypic level thanks to a mouse model of septicaemia, and compare them to the clinical data. The third aim, will establish and evaluate a simple clinical severity score (named COLISCORE), in order to help clinician evaluate patients' severity upon initial clinical evaluation and particularly to detect patients at risk of severe outcome. The ultimate goal of this work is to have a clinical impact on patients' management, by understanding the determinants of patient severity due to E. coli BSI in the context of current major epidemiological changes.
|Condition or disease|
|Escherichia Coli Bloodstream Infection|
|Study Type :||Observational|
|Actual Enrollment :||553 participants|
|Official Title:||Prognostic Factors of Escherichia Coli Bloodstream Infections in the Face of Emerging Multi-resistance, Severity Score and Therapeutic Implications|
|Actual Study Start Date :||October 13, 2016|
|Actual Primary Completion Date :||September 30, 2017|
|Actual Study Completion Date :||May 25, 2018|
- Death [ Time Frame: day 28 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890901
|Clichy, France, 92120|
|Principal Investigator:||victoire De Lastours||Assistance Publique - Hôpitaux de Paris|