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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03338738
Enrollment
19
Registered
2017-11-09
Start date
2018-07-19
Completion date
2021-05-28
Last updated
2021-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enterobacterial Infection

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.

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.

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.

Sponsors

Hospital Avicenne
CollaboratorOTHER
Fondation Hôpital Saint-Joseph
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
percentage of EBLSEDay 60ratio of number of colony of enterobacteria BLSE on number of total bacteria colony

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026