← Back to all trials
Enrolling By Invitation
NCT07818109
One Health Determinants of Rectal Colonization by ESBL-Producing Enterobacterales in the Community
Conditions: Antimicrobial Resistance (AMR), ESBL, Gut Microbiota Dysbiosis, Environmental Exposure, Carbapenemase-Producing Enterobacterales (CPE) Colonization, Carbapenemase-Producing Enterobacteriaceae, Carbapenemase-Producing Enterobacteriaceae (CPE)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 432
Sponsor: Hospital Italiano de Buenos Aires
Location: Hospital Italiano de Buenos Aires Buenos Aires Buenos Aires F.D.
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Adults aged 18 years or older.
* Resident for at least 1 year in one of the territorial areas included in the study.
* Community-dwelling individuals attending participating healthcare facilities (outpatient clinics, emergency departments, or hospitalized for less than 24 hours) or their accompanying family members/caregivers.
* Able and willing to provide informed consent.
* Able to provide fecal and urine samples.
Exclusion Criteria:
* Hospitalization within the previous 6 months.
* Antibiotic treatment within the previous 6 months.
* Current or recent oncologic treatment, immunotherapy, or immunosuppressive therapy within the previous 6 months.
* Use of laxatives within the previous 15 days.
* Pregnancy or breastfeeding.
* Inability to provide informed consent.
* Residence outside the study territorial areas.
Source: ClinicalTrials.gov (NCT07818109). StuddyBuddy aggregates publicly available trial information.
