An observational study in Antimicrobial Resistance (AMR), ESBL and Gut Microbiota Dysbiosis, sponsored by Hospital Italiano de Buenos Aires. Enrolling by invitation at 1 site in Argentina. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Hospital Italiano de Buenos Aires · Observational
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.
Antimicrobial resistance (AMR) is recognized as one of the greatest global public health threats. Although healthcare-associated drivers of AMR have been extensively studied, increasing evidence suggests that environmental, occupational, agricultural, socioeconomic, and ecological factors contribute substantially to the emergence and dissemination of resistant microorganisms in the community. The One Health approach recognizes the interconnectedness of human, animal, and environmental health and provides a comprehensive framework for understanding these complex interactions.
Extended-spectrum beta-lactamase (ESBL)-producing Enterobacterales represent one of the most relevant indicators of community-associated antimicrobial resistance. Intestinal colonization by ESBL-producing Enterobacterales serves as a reservoir for subsequent infections and transmission and has been proposed by the World Health Organization as a key surveillance indicator for monitoring antimicrobial resistance across human, animal, and environmental sectors.
This multicenter observational study aims to estimate the prevalence of intestinal colonization by ESBL-producing Enterobacterales among community-dwelling adults from different territorial regions of Argentina and to investigate biological, clinical, sociocultural, occupational, and environmental determinants associated with colonization.
The study is based on the hypothesis that colonization by ESBL-producing Enterobacterales is influenced not only by traditional healthcare-related factors and antibiotic exposure, but also by environmental and occupational determinants, including contact with food-producing animals, agricultural activities, water access, socioeconomic conditions, dietary patterns, and exposure to pesticides. Particular attention will be given to glyphosate exposure because of emerging evidence suggesting potential effects on microbial ecology and selection of resistant bacterial populations.
Participants will undergo collection of epidemiological information through standardized questionnaires addressing sociodemographic characteristics, medical history, medication use, occupational exposures, environmental conditions, dietary habits, animal contact, and other variables potentially related to antimicrobial resistance. Qualitative interviews will also be performed in selected participants to explore contextual and behavioral dimensions that may contribute to antimicrobial resistance emergence and dissemination.
Biological specimens will include fecal samples and urine samples. Microbiological analyses will be performed to identify intestinal colonization by ESBL-producing Enterobacterales. Isolates will undergo microbiological characterization and preservation for future molecular analyses. Fecal and urine specimens will be incorporated into an institutional biobank under established ethical and regulatory standards.
A subset of participants will undergo urinary glyphosate measurements based on environmental vulnerability indicators derived from questionnaire data. Glyphosate quantification will be performed using validated liquid chromatography-tandem mass spectrometry methods. Additional environmental biomarkers may be evaluated in the future depending on funding availability.
Future stages of the project will include integrated multi-omics analyses of fecal samples, including microbiome, resistome, metagenomic, metatranscriptomic, and metabolomic characterization. These analyses aim to investigate the relationship between microbial community composition, antimicrobial resistance determinants, environmental exposures, and intestinal colonization by resistant Enterobacterales.
The study will initially be conducted in two sentinel healthcare institutions representing different territorial contexts in Argentina: Hospital Italiano de Buenos Aires and Hospital J. B. Iturraspe in Santa Fe Province. The long-term objective is to expand the network to additional geographical regions and develop analytical ecological models capable of evaluating interactions between community-level determinants, microbiome composition, environmental exposures, and antimicrobial resistance.
By integrating microbiological, epidemiological, environmental, molecular, and qualitative information under a One Health framework, this study seeks to generate evidence regarding the mechanisms underlying community-associated antimicrobial resistance and to support the development of preventive strategies, surveillance initiatives, and public health interventions aimed at reducing the burden of antimicrobial resistance in Argentina.
187 studies on the registry are indexed under Dysbiosis; 64 are open to participants now.
This study's planned enrollment of 432 is above the median of 82 across 51 observational studies indexed under Dysbiosis.
Browse Dysbiosis studies →Hospital Italiano de Buenos Aires is the lead sponsor of 133 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of community-dwelling adults from selected territorial regions of Argentina recruited through sentinel healthcare facilities. Participants will be identified among adults attending outpatient clinics, emergency departments, or hospitalized for less than 24 hours, as well as accompanying family members or caregivers when applicable. Recruitment will be performed using a quota-based sampling strategy designed to achieve representation according to age, sex, and geographic area. The initial phase of the study will be conducted at Hospital Italiano de Buenos Aires and Hospital J. B. Iturraspe (Santa Fe Province), representing distinct territorial and socio-environmental contexts.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Community-dwelling adults with intestinal colonization by extended-spectrum beta-lactamase (ESBL)-producing Enterobacterales identified through microbiological analysis of fecal samples.
Prevalence of Intestinal Colonization by ESBL-Producing Enterobacterales
Proportion of participants with intestinal colonization by extended-spectrum beta-lactamase (ESBL)-producing Enterobacterales identified through microbiological analysis of fecal samples.
Time frame: Baseline (at enrollment)
Prevalence of Carbapenemase-Producing Enterobacterales Colonization
Proportion of participants colonized by carbapenemase-producing Enterobacterales detected through microbiological analysis.
Time frame: Baseline (at enrollment)
Urinary Glyphosate Detection
Frequency and concentration of urinary glyphosate among participants selected according to environmental vulnerability criteria.
Time frame: At enrollment
Gut Microbiota Characterization
Characterization of gut microbiota composition and diversity in stored fecal samples using molecular and multi-omics approaches, subject to funding availability.
Time frame: Up to 5 years after sample collection
Antimicrobial Resistance Gene Detection (Resistome)
Detection and characterization of antimicrobial resistance genes in fecal samples and bacterial isolates.
Time frame: Up to 5 years after sample collection
Biobank Collection Development
Creation and maintenance of a biobank collection including fecal samples, urine samples, bacterial isolates, and extracted DNA for future One Health research.
Time frame: Through study completion, an average of 2 years
Odds Ratio for Occupational Animal Contact and ESBL Colonization
Adjusted odds ratio (OR, 95% CI) for the association between occupational contact with food-producing animals (livestock, poultry, swine, or veterinary activities) and ESBL colonization status, derived from multivariable logistic regression using data collected through the structured epidemiological questionnaire.
Time frame: Time Frame: Baseline (at enrollment)
Odds Ratio for Water Source Access and ESBL Colonization
Adjusted odds ratio (OR, 95% CI) for the association between household water source and sanitation conditions and ESBL colonization status, derived from multivariable logistic regression using data collected through the structured epidemiological questio
Time frame: Time Frame: Baseline (at enrollment)
Odds Ratio for Dietary Habits and ESBL Colonization
Adjusted odds ratio (OR, 95% CI) for the association between dietary habits (consumption of animal-derived products and food sourcing practices) and ESBL colonization status, derived from multivariable logistic regression using data collected through the structured epidemiological questionnaire.
Time frame: Time Frame: Baseline (at enrollment)
Odds Ratio for Socioeconomic Indicators and ESBL Colonization
Adjusted odds ratio (OR, 95% CI) for the association between socioeconomic indicators (educational level and household socioeconomic status) and ESBL colonization status, derived from multivariable logistic regression using data collected through the structured epidemiological questionnaire.
Time frame: Time Frame: Baseline (at enrollment)
Odds Ratio for Healthcare-Related Exposures and ESBL Colonization
Adjusted odds ratio (OR, 95% CI) for the association between healthcare-related exposures (previous hospitalization, prior antibiotic use, and healthcare occupation) and ESBL colonization status, derived from multivariable logistic regression using data collected through the structured epidemiological questionnaire.
Time frame: Time Frame: Baseline (at enrollment)
Odds Ratio for Environmental Exposure Indicators and ESBL Colonization
Adjusted odds ratio (OR, 95% CI) for the association between environmental vulnerability indicators (housing characteristics and pesticide exposure indicators) and ESBL colonization status, derived from multivariable logistic regression using data collected through the structured epidemiological questionnaire.
Time frame: Time Frame: Baseline (at enrollment)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — The investigators have not yet determined whether individual participant data (IPD) will be shared. Future data sharing decisions will depend on participant consent, institutional policies, ethical approvals, data governance considerations, and the nature of planned microbiome, resistome, environmental exposure, and biobank-related analyses. Any future sharing of de-identified data will be conducted in accordance with applicable regulations and ethical requirements.
Started Jul 2025 (actual). Primary completion is estimated for Jul 2027, 24 months after the start.
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