Risk-factors for Multidrug-resistant Bacteria Colonization Among Patients at High Risk of STIs

Study Overview
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Brief Summary
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The aim of this study is to identify risk factors and prevalence of multidrug-resistant (MDR) and extensively drug-resistant (XDR) bacteria colonization among patients at high risk of STIs

Detailed Description
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The spread of multidrug-resistant (MDR) and extensively drug-resistant (XDR) bacteria have become a worldwide public health concern. Infection with MDR/XDR bacteria is associated with increased morbidity, increased risk of therapeutic failure and healthcare costs. The largest burden is from extended-spectrum betalactamase-producing enterobacteriaceae (ESBL) and carbapenem-resistant enterobacteriaceae (CRE). The World Health Organization (WHO) has considered the epidemic of MDR/XDR bacteria as a major health concern and has registered these bacteria in the priory pathogens list. This list includes pathogens for which new antibiotics are urgently needed. Moreover, in their recent report on ESBL, the French National Authorities of Health (HAS) has recommended that additional studies be conducted to improve knowledge about colonization risk factors. Some risk factors have been already identified: antibiotic intake and travel to countries with high MCR/XDR bacteria prevalence; however, many others are poorly identified. Patients visiting the CeGIDD (free information, screening and diagnosis center for sexually transmitted infections) and those receiving pre-exposure prophylaxis (PrEP) to prevent HIV infection are more exposed to STIs (including methicillin-resistant staphylococcus aureus, MRSA) and receive antibiotics for STI treatment. Moreover, an increase of STIs has been recently observed in men who have sex with men and in patients receiving PrEP. As antibiotic use is likely considerably increased in this population, we anticipate a high proportion with MDR/XDR colonization. The objective of the BMR-IST study is to identify risk-factors (i.e. sexual behaviors, HIV status, antiretroviral PrEP, STIs, antibiotic use and travel to epidemic countries) of MDR/XDR bacteria colonization among patients at high risk of acquiring STIs and to determine the prevalence of MDR colonization in the studied population.

Official Title
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Risk-factors for Multidrug-resistant (MDR) and Extensively Drug-resistant (XDR) Bacteria Colonization Among Patients at High Risk of STIs

Conditions
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Bacterial Infections, HIV Infections

Intervention / Treatment
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* Procedure: Inguinal swab sample
* Procedure: Anal swab sample
* Procedure: Fecal sample
* Other: Risk factor assessment


Participation Criteria
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Eligibility Criteria
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Cohort 1 - Inclusion Criteria: Age ≥ 18 years Consulting at the STI clinic of Saint-Antoine Hospital Signed the informed consent form Non-inclusion criteria: - No fluency in French Cohort 2 - Inclusion criteria: Men who have sex with men Seeking care at Saint-Antoine Hospital HIV-positive Non-inclusion criteria: - No fluency in French

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Main study group (HIV-negative)<br>2000 HIV-negative individuals seeking care at the STI clinic of Saint-Antoine Hospital Inguinal swab sample Anal swab sample Fecal sample Risk factor assessment | Procedure: Inguinal swab sample<br>* Inguinal samples using swab at cross-sectional visit<br>* Other names: ESwab;Procedure: Anal swab sample<br>* Anal samples using swab at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization)<br>* Other names: ESwab;Procedure: Fecal sample<br>* Fecal sample at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization)<br>Other: Risk factor assessment<br>* Patients will be asked questions on risk factors associated with MDR/XDR colonization at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization<br>|
| Exposure-matched group (HIV-positive)<br>500 HIV-positive men who have sex with men from the Infectious Diseases Unit of Saint- Antoine Hospital. These individuals will be compared to 500 HIV-negative MSM from the main study group, matching on age (+/-5 years). Inguinal swab sample Anal swab sample Fecal sample Risk factor assessment | Procedure: Inguinal swab sample<br>* Inguinal samples using swab at cross-sectional visit<br>* Other names: ESwab;Procedure: Anal swab sample<br>* Anal samples using swab at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization)<br>* Other names: ESwab;Procedure: Fecal sample<br>* Fecal sample at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization)<br>Other: Risk factor assessment<br>* Patients will be asked questions on risk factors associated with MDR/XDR colonization at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of ESBL and/or CRE colonization | Proportion of participants with ESBL and/or CRE colonization | 0 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loss of ESBL and/or CRE colonization after 6 months | Proportion of ESBL and/or CRE colonized participants no longer colonized at 6 months | 6 months | 
| STI prevalence | Proportion of participants with an STIs | 0 months | 
| Prevalence of ESBL and/or CRE colonization in the HIV-negative MSM group | Proportion of HIV-negative MSM participants with ESBL and/or CRE colonization | 0 months | 
| Prevalence of ESBL and/or CRE colonization in the HIV-positive MSM group | Proportion of HIV-positive MSM participants with ESBL and/or CRE colonization | 0 months | 
| Prevalence of ESBL and/or CRE colonization in the PrEP group | Proportion of participants undergoing PrEP with ESBL and/or CRE colonization | 0 months | 
| Prevalence of ESBL and/or CRE colonization in those with previous antibiotic exposure | Proportion of participants having previous antibiotic exposure with ESBL and /or CRE colonization | 0 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MDR, XDR, ESBL, ESBL, MRSA, CRE, HIV, PrEP, CeGIDD, STI, bacteria colonization