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临床试验/NCT05798247
NCT05798247已完成不适用

Cutaneous Diphtheria in France : an Observational, Retrospective Study of Epidemiological, Clinical, Microbiological and Therapeutic Characteristics

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer42 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2023年4月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
63
试验地点
42
主要终点
Patients epidemiological data description

研究概览

简要总结

Toxigenic cutaneous diphtheria is a notifiable disease that is re-emerging in the world and particularly in France. A better description of the epidemiological characteristics, as well as a refinement of the clinical characteristics of patients with cutaneous diphtheria, are essential to better understand this pathology, which has important public health issues and whose diagnosis absence can have catastrophic consequences for the patient and their contacts. Microbiological data (species identification, toxigenicity or not, resistance profile...) will be transmitted by the national reference center for corynebacteria of the diphtheriae complex and then caregivers who have managed the corresponding patients with cutaneous diphtheria will be contacted.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Culture or PCR positive skin samples for corynebacteria diphtheria, ulcerans, pseudotuberculosis, belfantii or rouxii
  • Patient living in metropolitan France

排除标准

  • Patient opposition

结局指标

主要结局

Patients epidemiological data description

时间窗: 3 months

Epidemiological data will be collected to describe the studied population (age, sex, place of birth, vaccination status...)

Patients therapeutic data description

时间窗: 3 months

Therapeutic data will be collected to describe the studied population (antibiotic therapy, duration of treatment, search for an eradication a posteriori...)

Patients clinical data description

时间窗: 3 months

Clinical data will be collected to describe the studied population (history, description of lesions, disease evolution, complications...)

Patients microbiological data description

时间窗: 3 months

Microbiological data will be collected to describe the studied population (species identification, toxigenicity, presence of a co-infection...)

次要结局

  • Comparison of post-infection serological sampling to national recommendations issued by the High Committee of Public Health(3 months)
  • Comparison of patient isolation procedures to national recommendations issued by the High Committee of Public Health(3 months)
  • Comparison of immunization status monitoring to national recommendations issued by the High Committee of Public Health(3 months)
  • Comparison of antibiotic therapy duration to national recommendations issued by the High Committee of Public Health(3 months)
  • Comparison of patient post infection vaccination status to national recommendations issued by the High Committee of Public Health(3 months)
  • Comparison of patient microbiological follow-up to national recommendations issued by the High Committee of Public Health(3 months)

研究者

发起方
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
申办方类型
Other
责任方
Sponsor

研究点 (42)

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