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临床试验/NCT03976024
NCT03976024Unknown不适用

Necrotizing Bacterial Dermohypodermitis-necrotizing Fasciitis (DHBN-FN) Mono- or Multi-microbial Streptococcus Beta-haemolytic: Study of Carriage in Patients and Their Entourage

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Rate of beta-hemolytic streptococcus in patients with DHBN-FN

研究概览

简要总结

The aim of the study is to evaluate streptococcal carriage by swab, pharyngeal, anal and perineal in patients with DHBN-FN, in the entourage living under the same roof as well as patients with erysipelas

The main hypothesis is the major role of chronic porting of patients and entourage in DHBN-FN to SBH.

Indeed, the chronic pharyngeal / anal / perineal carriage could be a gateway following a transient bacteremia for a DHBN-FN.

The transmission of germs from the surrounding to the patient plays a major role:

At the gateway level in the case of exogenous DHBN-FN At the origin of chronic carriage in the case of endogenous DHBN-FN Transmission of germs from the patient to the surrounding area also plays an important role in increasing the risk of invasive SBH infections in the surrounding area.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • Major patient hospitalized for a DHBN-FN or erysipelas (clinical diagnosis determined at the entrance).
  • Signed informed consent.
  • Case contact
  • person of major age living under the same roof as a patient who has had a DHBN-FN.
  • Signed informed consent

排除标准

  • Minor patient
  • Immunosuppressed patient: active hematology, poorly controlled HIV, neutropenia (PNN <1000 / mm3).
  • Patient under guardianship or curatorship
  • Patient deprived of liberty by judicial or administrative decision
  • Patient not affiliated to a social security scheme and not a beneficiary of such a scheme
  • Case contact
  • Minor person
  • Person under tutorship or curatorship
  • Person deprived of liberty by judicial or administrative decision
  • Person not affiliated with a social security

结局指标

主要结局

Rate of beta-hemolytic streptococcus in patients with DHBN-FN

时间窗: Day 30

Evaluation of streptococcal carriage by swab, pharyngeal, anal and perineal in patients hospitalized for a DHBN-FN . Swabs made by the dermatologist. The detection of beta-hemolytic streptococcus will be made by culture

次要结局

  • Prevalence of SBH carriage at the time of diagnosis(Day 0, Day 10)
  • Sites of SBH carriage at the time of diagnosis(Day 0, Day 10)
  • Rate of beta-hemolytic streptococcus in patients with erysipelas(Day 0)
  • Rate of beta-hemolytic streptococcus in patients living under the same roof as patients with DHBN-FN(Up to 10 Days)
  • Main factors of streptococcal virulence(Day 0, Day 10)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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