- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02847065
The Association Between Advancing Age and Mortality at 30 Days in Patients With Bacteremia E. Coli Beta-lactamase Phenotype Extended Spectrum RC15_0421 (MoBaCo)
September 20, 2021 updated by: Nantes University Hospital
Study Single-center, Uncontrolled, Retrospective, the Association Between Advancing Age and Mortality at 30 Days in Patients With Bacteremia E. Coli Beta-lactamase Phenotype Extended Spectrum
In the US and Europe, bacteremia are ranked the 7th leading cause of death from all causes.
E. coli is one of the main microorganism involved, responsible for 30% to 45% of bacteremia.
In Europe, bacteremia E. coli, including BLSE phenotype, have a strong impact on public health, causing increased mortality, particularly in the elderly, and an increase in the average hospital stay.
However, few studies have specifically concerned with the criteria associated with mortality of elderly patients with BLSE E. coli bacteremia.
Finally, improving epidemiological knowledge of the elderly patients with bacteremia due to BLSE E. coli has importance in terms of public health and is a prerequisite to the development of preventive strategies and to improve the short-term prognosis.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
144
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nantes, France
- CHU Nantes
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 105 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All data concerning blood cultures analyzed in the bacteriology department of University Hospital of Nantes are stored digitally, particularly E. coli ESBL.
Thus, the extraction of these data will allow the retrospective inclusion of patients and enhance the feasibility of the study.
Description
Inclusion Criteria:
All patients with positive blood culture E. coli BLSE will be included in the study. Bacteremia E. coli BLSE will be defined as the identification of one or more blood cultures positive for E. coli BLSE in patients with clinical criteria of systemic inflammatory response, at least two of the following 4 criteria:
- temperature> 38 ° C or < 36 ° C;
- heart rate> 90 beat / min;
- respiratory rate > 20 c / min or PaCO2 < 32 mmHg;
- WBC > 12,000 / microL or < 4000 / microL or 10% immature forms
Exclusion Criteria:
- For each patient included, only the first episode of bacteremia will be included in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Association between advancing age and mortality at 30 days in patients with bacteremia E. coli beta-lactamase phenotype extended spectrum.
Time Frame: 30 days
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30 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 3, 2015
Primary Completion (Actual)
April 30, 2016
Study Completion (Actual)
April 30, 2016
Study Registration Dates
First Submitted
July 21, 2016
First Submitted That Met QC Criteria
July 26, 2016
First Posted (Estimate)
July 27, 2016
Study Record Updates
Last Update Posted (Actual)
September 21, 2021
Last Update Submitted That Met QC Criteria
September 20, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC15_0421
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Beta-lactamase Extended Spectrum, E. Coli, Elderly, Mortality, Risk Factor
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University Hospital, Basel, SwitzerlandGebert Rüf-StiftungActive, not recruitingExtended Spectrum Beta Lactamases (ESBL) E. ColiSwitzerland