Factors Influencing the Fecal Relative Abundance of ESBL-producing Enterobacteriaceae in Intensive Care (BLSE-REA).

ESBL-producing Enterobacteriaceae Infections Clinical Trial

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 ?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04190316
• Other study ID #: RCB 2019-A02861-56
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: December 2019
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enterobacteriaceae Infections
• ESBL-producing Enterobacteriaceae Infections

Intervention

Other:
• Evaluation of fecal RA and environmental contamination of ESBL-PE carrier in ICU
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0, 3, 5, 7, 10, 14 and weekly till day 30.
Secondary	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	Day 0, 3, 5, 7, 10, 14 and weekly till day 30.
Secondary	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	Day 0, 3, 5, 7, 10, 14 and weekly till day 30.
Secondary	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	Day 0, 3, 5, 7, 10, 14 and weekly till day 30.
Secondary	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	Twice a week till day 30.
Secondary	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	Day 0, 3, 5, 7, 10, 14 and weekly till day 30.
Secondary	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	Day 0, 3, 5, 7, 10, 14 and weekly till day 30.