Risk-factors for Multidrug-resistant Bacteria Colonization Among Patients at High Risk of STIs
NCT ID: NCT03767374
Last Updated: 2024-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2186 participants
OBSERVATIONAL
2018-05-11
2020-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Main study group (HIV-negative)
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
Inguinal swab sample
Inguinal samples using swab at cross-sectional visit
Anal swab sample
Anal samples using swab at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization)
Fecal sample
Fecal sample at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization)
Risk factor assessment
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
Exposure-matched group (HIV-positive)
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
Inguinal swab sample
Inguinal samples using swab at cross-sectional visit
Anal swab sample
Anal samples using swab at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization)
Fecal sample
Fecal sample at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization)
Risk factor assessment
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
Interventions
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Inguinal swab sample
Inguinal samples using swab at cross-sectional visit
Anal swab sample
Anal samples using swab at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization)
Fecal sample
Fecal sample at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization)
Risk factor assessment
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Consulting at the STI clinic of Saint-Antoine Hospital
* Signed the informed consent form
\- No fluency in French
Cohort 2 -
* Men who have sex with men
* Seeking care at Saint-Antoine Hospital
* HIV-positive
\- No fluency in French
18 Years
ALL
Yes
Sponsors
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ANRS, Emerging Infectious Diseases
OTHER_GOV
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
OTHER
Responsible Party
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Principal Investigators
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Laure Surgers, MD
Role: PRINCIPAL_INVESTIGATOR
Saint-Antoine Hospital, Paris, France 75012
Locations
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CeGIDD and Infections Diseases Unit
Paris, , France
Countries
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References
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Other Identifiers
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IMEA 52
Identifier Type: -
Identifier Source: org_study_id
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