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

NCT04190316 | Unknown

• 1 other identifier: RCB 2019-A02861-56
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

ESBL-producing Enterobacteriaceae Infections

Keywords

Extended-spectrum beta-lactamase; Carriage; Cross transmission; Intensive care unit; Fecal relative abundance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Association between changes in ESBL-PE RA in fecal samples and ESBL-PE infection

  Day 0, 3, 5, 7, 10, 14 and weekly till day 30.

• Association between changes in ESBL-PE RA in fecal samples and ESBL-PE cross-transmission

  Day 0, 3, 5, 7, 10, 14 and weekly till day 30.

• Association between changes in ESBL-PE RA in fecal samples and multiple-site colonization

  Day 0, 3, 5, 7, 10, 14 and weekly till day 30.

• Association between changes in ESBL-PE RA in fecal samples and patient care environment contamination with ESBL-PE

  Twice a week till day 30.

• Comparison of changes in ESBL-PE RA between different bacteria species during ICU stay

  Day 0, 3, 5, 7, 10, 14 and weekly till day 30.

Study Arms (1)

Evaluation of patient and patient-care environment ESBL

OTHER

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.

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

Interventions

Evaluation of fecal RA and environmental contamination of ESBL-PE carrier in ICU OTHER

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.

Evaluation of patient and patient-care environment ESBL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Positive sample for ESBL-PE at admission of during ICU stay
• Patient's or relative's consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

MeSH Terms

Interventions

Intensive Care Units

Intervention Hierarchy (Ancestors)

Hospital Units; Health Facilities; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 9, 2019
• Study Start: January 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: December 9, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share