Informations générales (source: ClinicalTrials.gov)
Can the Relative Fecal Abundance of BLSE and the Digestive Microbiota be Predictive of the Risk of Infection in a Carrier Patient? (COPROBLSE2)
Interventional
N/A
Fondation Hôpital Saint-Joseph (Voir sur ClinicalTrials)
mars 2022
décembre 2024
29 juin 2024
Among Enterobacteriaceae, the production of beta-lactamases (ESBLs) is the leading cause
of multi-resistance. The first cases of ESBL-producing Enterobacteriaceae (E-ESBL)
infections were described in the 1980s and subsequently experienced worldwide
dissemination.
Since the turn of the century, the prevalence of E-ESBL infections, especially among
Escherichia coli (E. coli) and Klebsiella pneumoniae (K. pneumoniae) has increased
dramatically.
The emergence of multidrug-resistant Enterobacteriaceae is currently a real public health
problem. The European Antimicrobial Resistance Surveillance Network evaluated, among
clinical strains, the rate of resistance to 3rd generation cephalosporins (C3G) at 9.5%
for E. coli and 28% for K. pneumoniae. Numerous studies have shown that bacterial
colonization is the prerequisite for the occurrence of many infections.
However, the existence of prior colonization does not seem to be the only risk factor for
the occurrence of a secondary infection. Therefore, in patients with multidrug-resistant
Gram-negative bacillus gastrointestinal carriage there appear to be factors associated
with the onset of infection. Several studies have examined the risk factors associated
with E-ESBL-related infections in both community-based and healthcare-associated /
nosocomial infections. Two main risk factors seem to be associated with E-ESBL
infections: prior antibiotic therapy and the existence of invasive devices.
A recent study, carried out on 1288 patients and aimed at validating a predictive score
for the occurrence of ESBL-E bacteremia, demonstrated 5 factors associated with the
appearance of E-ESBL-linked bacteremia. These factors were: (i) a history of colonization
/ infection with ESBL-E, (ii) age ≥ 43 years, (iii) recent hospitalization in a region
with a high prevalence of ESBL-E, (iv) antibiotic therapy ≥ 6 days in the previous 6
months and (v) the existence of a chronic vascular access.
Recently, a retrospective case-control study conducted in the United States by Augustine
et al. Suggested that 5% of cases of bacteremia were related to ESBL-E.
Few studies have looked at risk factors for infection in patients known to be colonized
by the digestive system. In a retrospective case-control study, conducted outside the
intensive care unit and including pediatric and adult patients, the authors identified 2
factors associated with the occurrence of Ec-ESBL infection in previously colonized
patients. These two factors were the prior use of antibiotics with β-lactam antibiotics
and β-lactamase inhibitor (s), and urinary catheterization.
In intensive care hospital patients, the occurrence of ESBL-producing enterobacteriaceae
infection appears to be a rare event, including in colonized patients.
The work of Ruppé et al. showed a direct link between relative fecal abundance of
EScher-producing Escherichia coli and prior antibiotic intake.
This work also demonstrated a link between the value of the relative fecal abundance in
Ec-ESBL and the occurrence of a urinary tract infection linked to the same clone. In
particular, the authors found that women with a low relative fecal abundance rate (≤
0.1%) had no risk of developing an Escherichia coli urinary tract infection. Conversely,
the risk increased with the relative fecal abundance of Escherichia coli, but with a
positive predictive value limited to 57% for relative fecal abundances between 10 and
100%.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Avicenne | Jean-Ralph Zahar, MD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Necker-Enfants Malades | Claire ROUZAUD, MD | Contact (sur clinicalTrials) | |||
| CTRE EXAMENS SANTE CORBEIL ESSONNES | Didier LECOINTE, MD | Contact (sur clinicalTrials) | |||
| GH PARIS SITE SAINT JOSEPH | Benoit PILMIS, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Adult patient (≥ 18 years old) hospitalized at the Paris Saint-Joseph Hospital Group
or in the intensive care unit of Avicenne hospital, Necker Enfants Malades hospital,
Center Sud Francilien, detected as a carrier of enterobacteriaceae in the digestive
system ESBL producers
- Patient affiliated to a health insurance plan
- French-speaking patient
- Patient living at home, in EHPAD or retirement home
- Patient or Relative able to give free, informed and express consent
- Adult patient (≥ 18 years old) hospitalized at the Paris Saint-Joseph Hospital Group
or in the intensive care unit of Avicenne hospital, Necker Enfants Malades hospital,
Center Sud Francilien, detected as a carrier of enterobacteriaceae in the digestive
system ESBL producers
- Patient affiliated to a health insurance plan
- French-speaking patient
- Patient living at home, in EHPAD or retirement home
- Patient or Relative able to give free, informed and express consent
- Known patient colonized rectally with ESBL-producing enterobacteria and subjected to
antibiotic pressure other than beta-lactams
- Patient participating simultaneously in other intervention research that may
interfere with the objectives of the study
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Pregnant or breastfeeding woman