Impact of Beta-lactams on the Microbiota and Relative Fecal Abundance of Mulltidrug Resistant Bacteria

NCT03338738 | Completed

• 1 other identifier: COPROBLSE
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The global spread of ESBL-producing enterobacteria (EBLSE) poses a real public health problem. The exposure of patients to antibiotic therapy leads to an increase in resistant bacterial populations within the digestive flora. As a result, the diagnosis of digestive colonization by EBLSE is an event that has become common in hospitalized patients in intensive care / intensive care under high pressure antibiotics. The aim of this work is to study the impact of beta-lactams frequently prescribed on the microbiota and the emergence of multiresistant bacteria in the digestive flora and to evaluate, in colonized patients, the factors associated with the occurrence of an infectious episode. In particular, the impact of the relative fecal abundance of ESBL enterobacteriaceae on the occurrence of this event will be studied.

Conditions

Enterobacterial Infection

Outcome Measures

Primary Outcomes (1)

• percentage of EBLSE

  ratio of number of colony of enterobacteria BLSE on number of total bacteria colony

  Day 60

Study Arms (1)

Patients with ESBL, antibiotic pressure

EXPERIMENTAL

Patients with ESBL, antibiotic pressure will be included. On the day of inclusion, a stool culture is performed on the first stool issued after the start of antibiotic therapy in order to evaluate the initial flora and the relative initial faecal abundance of multidrug-resistant bacteria. In the absence of stool emission by the patient, a rectal swab will be performed. 72 hours after initiation of antibiotic therapy, a blood sample (5 ml) will be taken to determine plasma concentrations of antibiotics. In addition, a stool sample will be taken at 72 hours after the start of antibiotic therapy, at the end of antibiotic therapy and 60 days after this end to evaluate the change in initial flora and relative faecal abundance of ESBL-producing enterobacteria.

Diagnostic Test: Stool culture ans swab

Interventions

Stool culture ans swab DIAGNOSTIC_TEST

Patients with ESBL enterobacteria, antibiotic pressure are patients with ESBL positive result diagnosed by stool culture and a rectal swab. The intervention correspond to addition of 4 stool samples (or 4 rectal swabs in the absence of stool emission) and a blood sample.

Patients with ESBL, antibiotic pressure

Eligibility Criteria

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

You may qualify if:

• age\> 18
• ICU admitted patient
• rectal colonization of Enterobacteria
• accepting participation
• with medical insurance

You may not qualify if:

• patient without bacterial colonization
• under antibiotics more than 24hours
• without medical insurance

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead
• Hospital Avicenne: collaborator

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Related Publications (1)

• Pilmis B, Mizrahi A, Pean de Ponfilly G, Philippart F, Bruel C, Zahar JR, Le Monnier A. Relative faecal abundance of extended-spectrum beta-lactamase-producing Enterobacterales and its impact on infections among intensive care unit patients: a pilot study. J Hosp Infect. 2021 Jun;112:92-95. doi: 10.1016/j.jhin.2021.03.022. Epub 2021 Mar 29.

  PMID: 33794294 RESULT

MeSH Terms

Conditions

Enterobacteriaceae Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• ZAHAR Jean Ralph, Professor

  AVICENNE HOSPITAL

  STUDY CHAIR

• LE MONNIER Alban, Professor

  GHPSJ

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: November 9, 2017
• Study Start: July 19, 2018
• Primary Completion: March 31, 2021
• Study Completion: May 28, 2021
• Last Updated: June 2, 2021

Record last verified: 2021-05

Locations

FR (1)