One Health: Determinants of Rectal Colonization by Extended-Spectrum Beta-Lactamase-Producing Enterobacterales in Community-Dwelling Adults in Argentina
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 432
- 试验地点
- 1
- 主要终点
- Prevalence of Intestinal Colonization by ESBL-Producing Enterobacterales
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Prevalence of Intestinal Colonization by ESBL-Producing Enterobacterales
时间窗: Baseline (at enrollment)
Proportion of participants with intestinal colonization by extended-spectrum beta-lactamase (ESBL)-producing Enterobacterales identified through microbiological analysis of fecal samples.
次要结局
- 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)
- Odds Ratio for Occupational Animal Contact and ESBL Colonization(Time Frame: Baseline (at enrollment))
- Odds Ratio for Water Source Access and ESBL Colonization(Time Frame: Baseline (at enrollment))
- Odds Ratio for Dietary Habits and ESBL Colonization(Time Frame: Baseline (at enrollment))
- Odds Ratio for Socioeconomic Indicators and ESBL Colonization(Time Frame: Baseline (at enrollment))
- Odds Ratio for Healthcare-Related Exposures and ESBL Colonization(Time Frame: Baseline (at enrollment))
- Odds Ratio for Environmental Exposure Indicators and ESBL Colonization(Time Frame: Baseline (at enrollment))
研究者
SILVANA FIGAR
Principal Investigator
Hospital Italiano de Buenos Aires