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One Health Determinants of Rectal Colonization by ESBL-Producing Enterobacterales in the Community

StatusEnrolling by Invitation
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
This multicenter cross-sectional observational study aims to determine the prevalence of rectal colonization by extended-spectrum beta-lactamase (ESBL)-producing Enterobacterales among community-dwelling adults in Argentina and to identify biological, clinical, sociocultural, occupational, and environmental factors associated with colonization. Participants will be recruited from sentinel healthcare centers and will undergo collection of rectal swabs, fecal samples, urine samples, and standardized epidemiological questionnaires. The study is based on a One Health framework and will evaluate potential determinants of antimicrobial resistance, including previous healthcare exposure, antibiotic use, animal contact, occupational exposures, environmental conditions, water access, dietary habits, and pesticide exposure. Biological samples will be stored in an institutional biobank for future molecular, microbiome, resistome, and toxicological analyses. Findings are expected to improve understanding of community-associated antimicrobial resistance and support the development of preventive public health strategies.
Trial Details
NCT Number NCT07818109
Lead Sponsor Hospital Italiano de Buenos Aires
Collaborators: National Scientific and Technical Research Council (CONICET), Argentina
Conditions
(from sponsor)
Antimicrobial Resistance (AMR), ESBL, Gut Microbiota Dysbiosis, Environmental Exposure, Carbapenemase-Producing Enterobacterales (CPE) Colonization, Carbapenemase-Producing Enterobacteriaceae, Carbapenemase-Producing Enterobacteriaceae (CPE)
Enrollment 432 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov