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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

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Enterobacteriaceae Infections with a site in France — 3 open to participants now, 3 under way, 1 of them phase 3. Enterobacteriaceae Infections · France.

Started
2018
with 1 other
No phase
2 of 12
none open now
Registered
2nd of 12
by date
Lead sponsor
2 of 12
Fondation Hôpital Saint-Joseph

Among the 12 studies in Enterobacteriaceae Infections with a site in France, this one is one of 2 that started in 2018, is one of 2 with no phase, and was the 2nd registered.

Enterobacteriaceae Infections

59 studies on the registry are indexed under Enterobacteriaceae Infections; 14 are open to participants now.

Browse Enterobacteriaceae Infections studies →

Open to participants now

3 of the 12 studies in Enterobacteriaceae Infections with a site in France are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 9 Enterobacteriaceae Infections studies recruiting now, 4 set no upper age limit and 2 stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

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.

03

Conditions studied

  • Enterobacterial Infection
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
05

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.

06

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

07

Study locations

1 site
  • Groupe Hospitalier Paris Saint Joseph
    Paris, Ile-de-France 75014, France
08

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2018 to primary completion in Mar 2021, 32 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2017
First posted
Nov 9, 2017
StartActual
Jul 19, 2018
Primary completionActual
Mar 31, 2021
CompletionActual
May 28, 2021
Last update
Jun 2, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03338738
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 ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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