CeGIDD and Infections Diseases Unit
Paris, 75012, France
NCT Number: NCT03767374
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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Notify Me18 year and older
All sexes
Observational
Paris, 75012, France
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Cohort 1 -
Inclusion criteria
Non-inclusion criteria:
Cohort 2 -
Inclusion criteria
Non-inclusion criteria:
Inguinal samples using swab at cross-sectional visit
Other names: ESwab
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 at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization)
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
Time frame: 0 months
Proportion of participants with ESBL and/or CRE colonization
Time frame: 6 months
Proportion of ESBL and/or CRE colonized participants no longer colonized at 6 months
Time frame: 0 months
Proportion of participants with an STIs
Time frame: 0 months
Proportion of HIV-negative MSM participants with ESBL and/or CRE colonization
Time frame: 0 months
Proportion of HIV-positive MSM participants with ESBL and/or CRE colonization
Time frame: 0 months
Proportion of participants undergoing PrEP with ESBL and/or CRE colonization
Time frame: 0 months
Proportion of participants having previous antibiotic exposure with ESBL and /or CRE colonization
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Other
Risk-factors for Multidrug-resistant (MDR) and Extensively Drug-resistant (XDR) Bacteria Colonization Among Patients at High Risk of STIs
Acronym: BMR-IST
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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