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Completed

NCT Number: NCT03767374

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inguinal swab sample

Procedure

Inguinal samples using swab at cross-sectional visit

Other names: ESwab

Anal swab sample

Procedure

Anal samples using swab at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization)

Other names: ESwab

Fecal sample

Procedure

Fecal sample at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization)

Risk factor assessment

Other

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

Primary outcomes

  1. Prevalence of ESBL and/or CRE colonization

    Time frame: 0 months

    Proportion of participants with ESBL and/or CRE colonization

Secondary outcomes

  1. Loss of ESBL and/or CRE colonization after 6 months

    Time frame: 6 months

    Proportion of ESBL and/or CRE colonized participants no longer colonized at 6 months

  2. STI prevalence

    Time frame: 0 months

    Proportion of participants with an STIs

  3. Prevalence of ESBL and/or CRE colonization in the HIV-negative MSM group

    Time frame: 0 months

    Proportion of HIV-negative MSM participants with ESBL and/or CRE colonization

  4. Prevalence of ESBL and/or CRE colonization in the HIV-positive MSM group

    Time frame: 0 months

    Proportion of HIV-positive MSM participants with ESBL and/or CRE colonization

  5. Prevalence of ESBL and/or CRE colonization in the PrEP group

    Time frame: 0 months

    Proportion of participants undergoing PrEP with ESBL and/or CRE colonization

  6. Prevalence of ESBL and/or CRE colonization in those with previous antibiotic exposure

    Time frame: 0 months

    Proportion of participants having previous antibiotic exposure with ESBL and /or CRE colonization

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • ANRS, Emerging Infectious Diseases

Registry information

Official study title

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

Acronym: BMR-IST

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Dec 6, 2018
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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