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CompletedNCT03338738Updated Jun 2, 2021

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

An interventional study of Stool culture ans swab in Enterobacterial Infection, sponsored by Fondation Hôpital Saint-Joseph. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-02.

Sponsored by Fondation Hôpital Saint-Joseph · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Among enterobacteria, the production of ESBL is the first cause of multi-resistance. The consequences of multidrug-resistant enterobacterial infections predominantly represented by ESBLs are currently well known, both from the individual point of view (increase in mortality and length of hospital stay) and collective (increase in costs of care). Data from the literature reveal an increased risk of ESBL bacteremia in patients with rectal carriage of ESBL-producing enterobacteria. It therefore appears necessary in known patients with ESBL-producing enterobacteria to evaluate the impact of different antibiotics (beta-lactams) on the modification of flora, the increase of faecal abundance in multidrug-resistant bacteria such as E. coli ESBL and evaluate the factors associated with infections in these patients.

02

Conditions studied

  • Enterobacterial Infection
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patient without bacterial colonization
  • under antibiotics more than 24hours
  • without medical insurance
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    Patients with ESBL, antibiotic pressure

    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

  • Diagnostic testStool culture ans swab

    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.

05

What researchers measure

Primary outcomes

  1. percentage of EBLSE

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

    Time frame: Day 60

06

Study locations

1 site
  • Groupe Hospitalier Paris Saint Joseph
    Paris, Ile-de-France 75014, France
07

References and documents

Publications

  • 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. PubMed 33794294 ↗
08

Registry details

Key details

Study ID
NCT03338738
Lead sponsor
Fondation Hôpital Saint-Joseph
Collaborators
Hospital Avicenne
Responsible party
Sponsor
First posted
Nov 9, 2017
Start date
Jul 19, 2018
Primary completion
Mar 31, 2021
Completion
May 28, 2021
Last update
Jun 2, 2021

Study contacts

ZAHAR Jean Ralph, Professor
study chair · AVICENNE HOSPITAL
LE MONNIER Alban, Professor
study director · GHPSJ

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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