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

Completed

• Conditions: Bacterial Infections; HIV Infections
• Interventions: Procedure: Inguinal swab sample; Procedure: Anal swab sample; Procedure: Fecal sample; Other: Risk factor assessment

• Registration Number: NCT03767374
• Lead Sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-05-11
• Study First Submitted: 2018-12-05
• Study First Submitted QC: 2018-12-05
• Study First Posted: 2018-12-06
• Primary Completion: 2019-06-30
• Study Completion: 2020-12-31
• Status Verified: 2022-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2186

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposure-matched group (HIV-positive)	Fecal sample	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
Exposure-matched group (HIV-positive)	Risk factor assessment	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
Main study group (HIV-negative)	Fecal sample	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
Main study group (HIV-negative)	Risk factor assessment	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
Main study group (HIV-negative)	Inguinal swab sample	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
Main study group (HIV-negative)	Anal swab sample	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
Exposure-matched group (HIV-positive)	Inguinal swab sample	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
Exposure-matched group (HIV-positive)	Anal swab sample	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

Primary Outcome Measures

Name	Time	Method
Prevalence of ESBL and/or CRE colonization	0 months	Proportion of participants with ESBL and/or CRE colonization

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CeGIDD and Infections Diseases Unit; 🇫🇷 Paris, France