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Trial record 22 of 751 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND culture

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

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ClinicalTrials.gov Identifier: NCT03338738
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : August 26, 2019
Sponsor:
Collaborator:
Hospital Avicenne
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

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.

Condition or disease Intervention/treatment Phase
Enterobacterial Infection Diagnostic Test: Stool culture ans swab Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official 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
Actual Study Start Date : July 19, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
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

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 Outcome Measures :
  1. percentage of EBLSE [ Time Frame: Day 60 ]
    ratio of number of colony of enterobacteria BLSE on number of total bacteria colony



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338738


Contacts
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Contact: PILMIS Benoit, MD 01 44 12 33 33 bpilmis@hpsj.fr
Contact: PHILIPPART Francois, MD fphilipart@hpsj.fr

Locations
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France
Groupe Hospitalier Paris Saint Joseph Recruiting
Paris, Ile-de-France, France, 75014
Contact: Helene BEAUSSIER, PharmD, PhD         
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Hospital Avicenne
Investigators
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Study Chair: ZAHAR Jean Ralph, Professor AVICENNE HOSPITAL
Study Director: LE MONNIER Alban, Professor GHPSJ

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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT03338738     History of Changes
Other Study ID Numbers: COPROBLSE
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Lactams
beta-Lactams
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents