Factors Influencing the Fecal Relative Abundance of ESBL-producing Enterobacteriaceae in Intensive Care (BLSE-REA).
Primary Purpose
ESBL-producing Enterobacteriaceae Infections
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Evaluation of fecal RA and environmental contamination of ESBL-PE carrier in ICU
Sponsored by
About this trial
This is an interventional prevention trial for ESBL-producing Enterobacteriaceae Infections focused on measuring Extended-spectrum beta-lactamase, Carriage, Cross transmission, Intensive care unit, Fecal relative abundance
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Positive sample for ESBL-PE at admission of during ICU stay
- Patient's or relative's consent
Exclusion Criteria:
- Women pregnant, parturient or breast-feeding during the study period
- Patient deprived of liberty by judicial or administrative decision
- Patient undergoing psychiatric care under duress
- Patient subject to a legal protection measure
- Patient with no social security coverage
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Evaluation of patient and patient-care environment ESBL
Arm Description
ESBL-PE carriers included in the study will be sampled for evaluation of their fecal RA of ESBL-PE on day 0, 3, 5, 7, 10, 14 and weekly till day 30 or their discharge from ICU. Urine and respiratory samples will be collected on the same day to identify multiple-site colonization with ESBL-PE. Seven samples of patient care environment will be performed 2-times a week till day 30 or discharge of the patient from the ICU.
Outcomes
Primary Outcome Measures
Changes in fecal ESBL-PE RA in the ICU
Factors associated with changes in the RA of ESBL-PE fecal carriage will be analyzed. RA is expressed by the ratio of ESBL-PE and total enterobacteriaceae.
Secondary Outcome Measures
Association between changes in ESBL-PE RA in fecal samples and ESBL-PE infection
Looking for a threshold of ESBL-PE RA in fecal sample and a high risk of ESBL-PE infection
Association between changes in ESBL-PE RA in fecal samples and ESBL-PE cross-transmission
Is there an association between a high ESBL-PE RA in fecal samples and cross-transmission
Association between changes in ESBL-PE RA in fecal samples and multiple-site colonization
Is there an association between a high ESBL-PE RA in fecal samples and multiple-site colonization
Association between changes in ESBL-PE RA in fecal samples and patient care environment contamination with ESBL-PE
Is there an association between a high ESBL-PE RA in fecal samples and patient care environment contamination with ESBL-PE
Comparison of changes in ESBL-PE RA between different bacteria species during ICU stay
Are there differences of RA between different species of ESBL-PE
Incidence of high level of EBSL-PE RA in ICU fecal carriers
High level of RA is defined by a ratio of ESBL-PE on total enterobacteriaceae > 0.2
Full Information
NCT ID
NCT04190316
First Posted
December 2, 2019
Last Updated
December 4, 2019
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT04190316
Brief Title
Factors Influencing the Fecal Relative Abundance of ESBL-producing Enterobacteriaceae in Intensive Care (BLSE-REA).
Official Title
Study of the Fecal Relative Abundance (RA) of ESBL-producing Enterobacteriaceae (ESBL-PE) in Intensive Care (BLSE-REA) : What Are the Factors Influencing the Fecal RA of ESBL-PE in ICU ?
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Anticipated)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Extended-Spectrum Beta-Lactamases (ESBL)-Producing Enterobacteriaceae (PE) pose a major problem among antimicrobial resistance. The worldwide spread of theses bacteria may be responsible for 10 million death in 2050. Infection with ESBL-PE are associated with a worse prognosis because of delay in the start of adequate antibiotic treatment, especially for severe infections. It has been proposed to identify colonized patients to predict the risk of infection and the risk of nosocomial cross transmission.
This qualitative approach has limit as only 5 to 20% of patients will develop an infection with ESBL-PE. The fecal relative abundance (RA) of ESBL-PE is a ratio of ESBL-PE among enterobacteriaceae that could identify high-risk patients of infection or cross transmission. ESBL-PE RA may be highly variable in patient with antibiotic exposure depending on the molecule received but dynamic data is missing.
The aim of this study is to identify the factor that influence the fecal RA of ESBL-PE in ICU and to evaluate the association between different level of fecal RA and infection or cross transmission with an ESBL-PE.
Detailed Description
Antimicrobial resistance is rising since decades with a risk of million of death in the future. Extended-Spectrum Beta-Lactamases (ESBL)-Producing Enterobacteriaceae (PE) have expanded exponentially since 15 years and represent with Carbapenemase-PE one of the major challenges in resistance control. The burden of ESBL-PE infections is major in intensive care units (ICU) because of the delay to identify an effective antibiotic treatment (highly associated with outcome) and because of a higher risk of nosocomial cross transmission.
Identification of digestive carrier of ESBL-PE is based on a qualitative result that categorize the patient as a carrier or as non-carrier. This result makes it impossible to individualize the measures to be taken for an ESBL-PE carrier.
Prevention of cross transmission has no formal guideline. Some practitioners in ICU have stopped to detect for ESBL-PE carriage (specially when prevalence is low) and other prefer to close the ward (specially during outbreak).
Empiric treatment of most infections in ESBL-PE carrier are based on last-resort antibiotic (i.e. carbapenem) until microbiological results of a clinical simple is available.
A quantitative approach based on fecal relative abundance (RA) of ESBL-PE (ratio between ESBL-PE and enterobacteriaceae) has been proposed to individualize the risk of urinary tract infection (UTI) for ambulatory patients. In this setting, a fecal carriage with a very low RA of ESBL-PE safely rule out a risk of infection with ESBL-PE and patients with a high RA had an increased risk of UTI infection with ESBL-PE. Large variations of RA ESBL-PE carriage was observed and prediction of the level of RA was not possible for a patient.
A high variation in fecal RA of ESBL-PE is probable in ICU because of a high proportion of antibiotic exposure. Using the RA in ICU for ESBL-PE carrier could make it possible to identify patients who need for carbapenem in their empiric treatment and those who need continuing contact precautions to prevent cross transmission.
The aim of this study is to identify the factor that influence the fecal RA of ESBL-PE in ICU and to evaluate the association between different level of fecal RA and infection or cross transmission with an ESBL-PE.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ESBL-producing Enterobacteriaceae Infections
Keywords
Extended-spectrum beta-lactamase, Carriage, Cross transmission, Intensive care unit, Fecal relative abundance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Evaluation of patient and patient-care environment ESBL
Arm Type
Other
Arm Description
ESBL-PE carriers included in the study will be sampled for evaluation of their fecal RA of ESBL-PE on day 0, 3, 5, 7, 10, 14 and weekly till day 30 or their discharge from ICU. Urine and respiratory samples will be collected on the same day to identify multiple-site colonization with ESBL-PE. Seven samples of patient care environment will be performed 2-times a week till day 30 or discharge of the patient from the ICU.
Intervention Type
Other
Intervention Name(s)
Evaluation of fecal RA and environmental contamination of ESBL-PE carrier in ICU
Intervention Description
ESBL-PE carriers included in the study will be sampled for evaluation of their fecal RA of ESBL-PE on day 0, 3, 5, 7, 10, 14 and weekly till day 30 or their discharge from ICU. Urine and respiratory samples will be collected on the same day to identify multiple-site colonization with ESBL-PE. Seven samples of patient care environment will be performed 2-times a week till day 30 or discharge of the patient from the ICU.
Primary Outcome Measure Information:
Title
Changes in fecal ESBL-PE RA in the ICU
Description
Factors associated with changes in the RA of ESBL-PE fecal carriage will be analyzed. RA is expressed by the ratio of ESBL-PE and total enterobacteriaceae.
Time Frame
Day 0, 3, 5, 7, 10, 14 and weekly till day 30.
Secondary Outcome Measure Information:
Title
Association between changes in ESBL-PE RA in fecal samples and ESBL-PE infection
Description
Looking for a threshold of ESBL-PE RA in fecal sample and a high risk of ESBL-PE infection
Time Frame
Day 0, 3, 5, 7, 10, 14 and weekly till day 30.
Title
Association between changes in ESBL-PE RA in fecal samples and ESBL-PE cross-transmission
Description
Is there an association between a high ESBL-PE RA in fecal samples and cross-transmission
Time Frame
Day 0, 3, 5, 7, 10, 14 and weekly till day 30.
Title
Association between changes in ESBL-PE RA in fecal samples and multiple-site colonization
Description
Is there an association between a high ESBL-PE RA in fecal samples and multiple-site colonization
Time Frame
Day 0, 3, 5, 7, 10, 14 and weekly till day 30.
Title
Association between changes in ESBL-PE RA in fecal samples and patient care environment contamination with ESBL-PE
Description
Is there an association between a high ESBL-PE RA in fecal samples and patient care environment contamination with ESBL-PE
Time Frame
Twice a week till day 30.
Title
Comparison of changes in ESBL-PE RA between different bacteria species during ICU stay
Description
Are there differences of RA between different species of ESBL-PE
Time Frame
Day 0, 3, 5, 7, 10, 14 and weekly till day 30.
Title
Incidence of high level of EBSL-PE RA in ICU fecal carriers
Description
High level of RA is defined by a ratio of ESBL-PE on total enterobacteriaceae > 0.2
Time Frame
Day 0, 3, 5, 7, 10, 14 and weekly till day 30.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
Positive sample for ESBL-PE at admission of during ICU stay
Patient's or relative's consent
Exclusion Criteria:
Women pregnant, parturient or breast-feeding during the study period
Patient deprived of liberty by judicial or administrative decision
Patient undergoing psychiatric care under duress
Patient subject to a legal protection measure
Patient with no social security coverage
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Factors Influencing the Fecal Relative Abundance of ESBL-producing Enterobacteriaceae in Intensive Care (BLSE-REA).
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