Risk-factors for Multidrug-resistant (MDR) and Extensively Drug-resistant (XDR) Bacteria Colonization Among Patients at High Risk of STIs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,186
- 试验地点
- 1
- 主要终点
- Prevalence of ESBL and/or CRE colonization
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Consulting at the STI clinic of Saint-Antoine Hospital
- •Signed the informed consent form
- •Non-inclusion criteria:
- •No fluency in French
- •Inclusion criteria:
- •Men who have sex with men
- •Seeking care at Saint-Antoine Hospital
- •HIV-positive
- •Non-inclusion criteria:
- •No fluency in French
排除标准
- 未提供
结局指标
主要结局
Prevalence of ESBL and/or CRE colonization
时间窗: 0 months
Proportion of participants with ESBL and/or CRE colonization
次要结局
- Prevalence of ESBL and/or CRE colonization in the PrEP group(0 months)
- STI prevalence(0 months)
- Loss of ESBL and/or CRE colonization after 6 months(6 months)
- Prevalence of ESBL and/or CRE colonization in the HIV-negative MSM group(0 months)
- Prevalence of ESBL and/or CRE colonization in the HIV-positive MSM group(0 months)
- Prevalence of ESBL and/or CRE colonization in those with previous antibiotic exposure(0 months)