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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 553 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Death [ Time Frame: day 28 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Escherichia coli bloostream infection
Criteria

Inclusion Criteria:

  • Isolation of E. coli from 1 or more set of aseptically inoculated blood culture bottle collected in one of the study centres
  • Age ≥ 18 year-old

Exclusion Criteria:

  • Receiving vasopressors before the onset of the bacteraemia
  • Patient previously included in the study
  • Patient's opposition

Information from the National Library of Medicine

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


Locations
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France
Hopital Beaujon
Clichy, France, 92120
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: victoire De Lastours Assistance Publique - Hôpitaux de Paris
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02890901    
Other Study ID Numbers: PRTS1511
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: May 29, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Escherichia coli
Bloodstream infections
Severity
Score
Host factors
Microbiology
Additional relevant MeSH terms:
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Infection
Communicable Diseases