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

NCT07818109 | Enrolling By Invitation DMC

• 1 other identifier: 7067
• Study Type: observational
• Target: 432
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Antimicrobial Resistance (AMR); Carbapenemase-Producing Enterobacteriaceae (CPE); ESBL; Gut Microbiota Dysbiosis; Environmental Exposure; Carbapenemase-Producing Enterobacterales (CPE) Colonization; Carbapenemase-Producing Enterobacteriaceae

Keywords

One Health; Antimicrobial Resistance; Glyphosate; Extended-Spectrum Beta-Lactamase; Community Colonization; Occupational Exposure; Environmental Exposure; Pesticides; Resistome; Microbiome; Gut Microbiota; CPE

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (at enrollment)

Secondary Outcomes (11)

• Prevalence of Carbapenemase-Producing Enterobacterales Colonization

  Baseline (at enrollment)

• Urinary Glyphosate Detection

  At enrollment

• Gut Microbiota Characterization

  Up to 5 years after sample collection

• Antimicrobial Resistance Gene Detection (Resistome)

  Up to 5 years after sample collection

• Biobank Collection Development

  Through study completion, an average of 2 years

Study Arms (1)

Participants Colonized by ESBL-Producing Enterobacterales

Community-dwelling adults with intestinal colonization by extended-spectrum beta-lactamase (ESBL)-producing Enterobacterales identified through microbiological analysis of fecal samples.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead
• National Scientific and Technical Research Council (CONICET), Argentina: collaborator

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, Buenos Aires F.D., 1199, Argentina

Location

Related Publications (5)

• Bressan IG, Llesuy SF, Rodriguez C, Ferloni A, Dawidowski AR, Figar SB, Gimenez MI. Optimization and validation of a liquid chromatography-tandem mass spectrometry method for the determination of glyphosate in human urine after pre-column derivatization with 9-fluorenylmethoxycarbonyl chloride. J Chromatogr B Analyt Technol Biomed Life Sci. 2021 May 1;1171:122616. doi: 10.1016/j.jchromb.2021.122616. Epub 2021 Mar 5.

  PMID: 33744598 BACKGROUND

• Raoult D, Hadjadj L, Baron SA, Rolain JM. Role of glyphosate in the emergence of antimicrobial resistance in bacteria? J Antimicrob Chemother. 2021 Jun 18;76(7):1655-1657. doi: 10.1093/jac/dkab102.

  PMID: 33893490 BACKGROUND

• Mackenzie JS, Jeggo M. The One Health Approach-Why Is It So Important? Trop Med Infect Dis. 2019 May 31;4(2):88. doi: 10.3390/tropicalmed4020088.

  PMID: 31159338 BACKGROUND

• Aslam B, Khurshid M, Arshad MI, Muzammil S, Rasool M, Yasmeen N, Shah T, Chaudhry TH, Rasool MH, Shahid A, Xueshan X, Baloch Z. Antibiotic Resistance: One Health One World Outlook. Front Cell Infect Microbiol. 2021 Nov 25;11:771510. doi: 10.3389/fcimb.2021.771510. eCollection 2021.

  PMID: 34900756 BACKGROUND

• Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet. 2022 Feb 12;399(10325):629-655. doi: 10.1016/S0140-6736(21)02724-0. Epub 2022 Jan 19.

  PMID: 35065702 BACKGROUND

Related Links

• WHO. WHO Integrated Global Surveillance on ESBL-Producing E. coli Using a One Health Approach: Implementation and Opportunities. Geneva: World Health Organization; 2021.
• Shehata AA, Schrödl W, Aldin AA, et al. The Effect of Glyphosate on Potential Pathogens and Beneficial Members of Poultry Microbiota In Vitro. Curr Microbiol. 2013;66:350-358.
• Figar S, Ferloni A, Saravi A, et al. Presence of glyphosate in urine due to environmental exposure among populations of agro-industrial areas in Buenos Aires, Argentina. bioRxiv. 2024. DOI:10.1101/2024.04.02.24305133.
• Figar SB, Ferloni A, Hough GE, Saravi A, Dawidowski AR, Aliperti VI, Bressán I, De Florio F, Vicens J, Braguinsky Golde N, Garcia NK, Pazur G, Gadano AC. Condicionantes de la presencia de glifosato en orina en poblaciones de zonas agroindustriales de la

Biospecimen

Retention: SAMPLES WITH DNA

Fecal samples, urine samples, bacterial isolates, extracted DNA, and other derived biological materials will be stored in the institutional biobank of Hospital Italiano de Buenos Aires for future microbiome, resistome, molecular, toxicological, and environmental exposure studies, subject to ethical approval and participant consent.

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: September 14, 2026
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 14, 2026

Record last verified: 2026-09

Locations

AR (1)