Risk-factors for Multidrug-resistant Bacteria Colonization Among Patients at High Risk of STIs (BMR-IST)

Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Status: Completed

Conditions: HIV Infections; Bacterial Infections

Treatments: Other: Risk factor assessment; Procedure: Inguinal swab sample; Procedure: Fecal sample; Procedure: Anal swab sample

Study type: Observational

Funder types: Other

Identifiers

NCT03767374

IMEA 52

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,186 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

2,186 participants in 2 patient groups

Main study group (HIV-negative)

Description:

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

Treatment:

Procedure: Anal swab sample

Procedure: Fecal sample

Procedure: Inguinal swab sample

Other: Risk factor assessment

Exposure-matched group (HIV-positive)

Description:

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

Treatment:

Procedure: Anal swab sample

Procedure: Fecal sample

Procedure: Inguinal swab sample

Other: Risk factor assessment