Escherichia Coli Bloodstream Infection Clinical Trial
— SEPTICOLIOfficial title:
Prognostic Factors of Escherichia Coli Bloodstream Infections in the Face of Emerging Multi-resistance, Severity Score and Therapeutic Implications
NCT number | NCT02890901 |
Other study ID # | PRTS1511 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 13, 2016 |
Est. completion date | May 25, 2018 |
Verified date | November 2017 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 553 |
Est. completion date | May 25, 2018 |
Est. primary completion date | September 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Hopital Beaujon | Clichy |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Death | day 28 |