Antimicrobial Resistance (AMR)NCT07818109
One Health Determinants of Rectal Colonization by ESBL-Producing Enterobacterales in the Community
An observational study of Antimicrobial Resistance (AMR) and ESBL, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Antimicrobial Resistance (AMR), ESBL, Gut Microbiota Dysbiosis
- How many people
- 432 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Jul 2025to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina1 site
Hospital Italiano de Buenos Aires
Buenos Aires, Buenos Aires F.D., 1199
About this study
Official title: One Health: Determinants of Rectal Colonization by Extended-Spectrum Beta-Lactamase-Producing Enterobacterales in Community-Dwelling Adults in Argentina
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.
Read the detailed description
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.
- Conditions
- Antimicrobial Resistance (AMR), 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (at enrollment)
Secondary outcomes (11)
Prevalence of Carbapenemase-Producing Enterobacterales Colonization
Proportion of participants colonized by carbapenemase-producing Enterobacterales detected through microbiological analysis.
Measured: Baseline (at enrollment)
Urinary Glyphosate Detection
Frequency and concentration of urinary glyphosate among participants selected according to environmental vulnerability criteria.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Time Frame: Baseline (at enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Jul 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Antimicrobial Resistance (AMR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 432 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Collaborators
- National Scientific and Technical Research Council (CONICET), Argentina
- Responsible party
- Principal investigator, SILVANA FIGAR, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818109
- Sponsor's protocol ID
- 7067
- Status last verified
- Sep 2026
- First submitted
- 2 Jul 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 33744598Raoult 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.
PubMed 33893490Mackenzie 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.
PubMed 31159338Aslam 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.
PubMed 34900756Antimicrobial 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.
PubMed 35065702
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Health: Determinants of Rectal Colonization by Extended-Spectrum Beta-Lactamase-Producing Enterobacterales in Community-Dwelling Adults in Argentina
- ClinicalTrials.gov ID
- NCT07818109
- Acronym / sponsor ID
- 7067
- Conditions
- Antimicrobial Resistance (AMR), 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
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 432 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Collaborators
- National Scientific and Technical Research Council (CONICET), Argentina
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Intestinal Colonization by ESBL-Producing Enterobacterales
Time frame: Baseline (at enrollment)
Proportion of participants with intestinal colonization by extended-spectrum beta-lactamase (ESBL)-producing Enterobacterales identified through microbiological analysis of fecal samples.
11 secondary outcomes
Prevalence of Carbapenemase-Producing Enterobacterales Colonization
Time frame: Baseline (at enrollment)
Urinary Glyphosate Detection
Time frame: At enrollment
Gut Microbiota Characterization
Time frame: Up to 5 years after sample collection
Antimicrobial Resistance Gene Detection (Resistome)
Time frame: Up to 5 years after sample collection
Biobank Collection Development
Time frame: Through study completion, an average of 2 years
Odds Ratio for Occupational Animal Contact and ESBL Colonization
Time frame: Time Frame: Baseline (at enrollment)
Odds Ratio for Water Source Access and ESBL Colonization
Time frame: Time Frame: Baseline (at enrollment)
Odds Ratio for Dietary Habits and ESBL Colonization
Time frame: Time Frame: Baseline (at enrollment)
Odds Ratio for Socioeconomic Indicators and ESBL Colonization
Time frame: Time Frame: Baseline (at enrollment)
Odds Ratio for Healthcare-Related Exposures and ESBL Colonization
Time frame: Time Frame: Baseline (at enrollment)
Odds Ratio for Environmental Exposure Indicators and ESBL Colonization
Time frame: Time Frame: Baseline (at enrollment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Background: PubMed 33744598Bressan 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.
- Background: PubMed 33893490Raoult 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.
- Background: PubMed 31159338Mackenzie 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.
- Background: PubMed 34900756Aslam 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.
- Background: PubMed 35065702Antimicrobial 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.
- WHO. WHO Integrated Global Surveillance on ESBL-Producing E. coli Using a One Health Approach: Implementation and Opportunities. Geneva: World Health Organization; 2021.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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 laLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
Related trials for Antimicrobial Resistance (AMR)
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
RecruitingObservational study
Prospective Study on Antimicrobial RESIstance in Chronic Pulmonary DiseasE
Chronic Lung Diseases
RecruitingObservational study
Implementation of a Sepsis Chart and Its Effects on Mortality Rate in Indonesian Primary Referral Hospitals
Sepsis, Antimicrobial Resistance (AMR)
Recruiting
Molecular-based Optimization of Pathogen Identification in Sepsis Patients in the Indonesian National Referral Hospital
Sepsis, Antimicrobial Resistance (AMR)
Active, not recruitingObservational study
Prevalence of Multidrug-Resistant Organism Infections in General Adult Wards in Argentina (PREV-AR 2 - IGA)
Multidrug-Resistant Organism Infection, Healthcare-Associated Infections (HAIs)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antimicrobial Resistance (AMR) and ESBL, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Intestinal Colonization by ESBL-Producing Enterobacterales (time frame: Baseline (at enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07818109, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.