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

Enterobacterial Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03338738
• Other study ID #: COPROBLSE
• Status: Completed
• Phase: N/A
• Start date: July 19, 2018
• Est. completion date: May 28, 2021

Study information

• Verified date: May 2021
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 28, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enterobacteriaceae Infections
• Enterobacterial Infection

Intervention

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.

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph	Hospital Avicenne

Country where clinical trial is conducted

France, 

References & Publications (1)

Pilmis B, Mizrahi A, Péan de Ponfilly G, Philippart F, Bruel C, Zahar JR, Le Monnier A. Relative faecal abundance of extended-spectrum ß-lactamase-producing Enterobacterales and its impact on infections among intensive care unit patients: a pilot study. J — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of EBLSE	ratio of number of colony of enterobacteria BLSE on number of total bacteria colony	Day 60