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OpenTrials
Completed

NCT Number: NCT03338738

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

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.

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Key information

Conditions

Enterobacterial Infection Bacterial Infections Bacterial Infections and Mycoses Enterobacteriaceae Infections Gram-Negative Bacterial Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe Hospitalier Paris Saint Joseph

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. percentage of EBLSE

    Time frame: Day 60

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

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Collaborators

  • Hospital Avicenne

Registry information

Official study title

Impact of Beta-lactams on the Microbiota and Relative Fecal Abundance of Multidrug Resistant Bacteria Ans Its Importance on Infectious Episodes in Hospitalized Patients

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 9, 2017
Registry last updated
Jun 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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