Assessing the risk of infection in patients with specific gut bacteria

Can the Relative Fecal Abundance of BLSE and the Digestive Microbiota be Predictive of the Risk of Infection in a Carrier Patient?

This study is trying to see if having certain gut bacteria can help predict the risk of infections in hospitalized adults, especially those who are either not taking antibiotics or are under antibiotic treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fondation Hôpital Saint-Joseph (other)
• Locations: 4 sites (Paris, Groupe Hospitalier Paris Saint-Joseph and 3 other locations)
• Trial ID: NCT04699981 on ClinicalTrials.gov

What this trial studies

This study investigates whether the relative abundance of beta-lactamase-producing Enterobacteriaceae (BLSE) and the overall digestive microbiota can predict the risk of infection in patients who are carriers of these bacteria. It involves two groups: one with patients colonized by ESBL-producing enterobacteria without antibiotic pressure and another with patients under antibiotic pressure. The research aims to understand the relationship between bacterial colonization and the occurrence of infections, particularly in hospitalized adults. The study is conducted in multiple hospitals in Paris, focusing on adult patients who meet specific inclusion criteria.

Who should consider this trial

Good fit: Ideal candidates are adult patients hospitalized in specific Paris hospitals who are carriers of ESBL-producing Enterobacteriaceae.

Not a fit: Patients currently under antibiotic pressure from non-beta-lactam antibiotics or those participating in conflicting studies may not benefit from this research.

Why it matters

Potential benefit: If successful, this study could lead to improved strategies for predicting and preventing infections in patients carrying multidrug-resistant bacteria.

How similar studies have performed: While the emergence of multidrug-resistant Enterobacteriaceae is a known issue, this specific approach to predicting infection risk based on gut microbiota is relatively novel.

Eligibility criteria

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

Exclusion Criteria:

* 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

Where this trial is running

Paris, Groupe Hospitalier Paris Saint-Joseph and 3 other locations

• Groupe Hospitalier Paris Saint-Joseph — Paris, Groupe Hospitalier Paris Saint-Joseph, France (RECRUITING)
• Hôpital Necker-Enfants malades — Paris, Groupe Hospitalier Paris Saint-Joseph, France (NOT_YET_RECRUITING)
• Hôpital Avicenne — Bobigny, France (NOT_YET_RECRUITING)
• Centre Hospitalier Sud-Francilien — Corbeil-Essonnes, France (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Benoit PILMIS, MD — Fondation Hôpital Saint-Joseph
• Study coordinator: Benoit PILMIS, MD

Conditions: Enterobacteria Infections