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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
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 2, 2019
    Last Updated
    December 4, 2019
    Sponsor
    University Hospital, Angers
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    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

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