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临床试验/NCT02565940
NCT02565940Unknown不适用

Study by Metagenomics and Culturomicsapproaches of Bacterial and Viral Flora of Diabetic Foot Infection

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
dermal sample

研究概览

简要总结

This work also highlights the presence of an unknown virus double-stranded DNA. In this project we propose 1) incorporating a bank of 150 samples from patients with diabetic foot infection in grades 2-4; 2) to study the microbial flora of a selection of 50 diabetic feet previously untreated with antibiotics for bacterial metagenomics, viral metagenomics and a minimum of 10 per culturomique; 3) to evaluate the use of targeted quantitative PCR on the most frequent new species frequency in the disease and incidentally get a sense of their role in the evolution and prognosis of the disease, including failures of and targeted antibiotic therapy on all 150 samples.

详细描述

Patients will be included by the infectious and tropical diseases and diabetes services the Nîmes Teaching Hospital which have a large active file and proven expertise internationally in this pathology. The usual agents of infection will be searched by standard bacteriological techniques as part of the microbiological documentation of such cases and will be performed by the microbiology laboratory of CHU Nîmes which will freeze the rest of the sample to -80 ° C the will send it to the Marseille Microbiology Federation for realization of metagenomics-culturomics

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Patients were taken care by the services(departments) of Diabetology or Infectious diseases of the CHU(TEACHING HOSPITAL) of Nîmes, were hospitalized or were seen in consultation and presenting a wound chronicle of the foot and/or the ankle of Rank 2 - 4 (Classification of the IWGDF) [IWGDF, Lipsky Clin Infect Dis on 2004], inaugural or récidivante.

排除标准

  • The patient participates in another study
  • The patient is in period of exclusion determined by a previous study
  • The patient is under protection(saving) of justice, under guardianship or under guardianship
  • The patient refuses to sign the consent
  • It turns out impossible to give about the lit(enlightened) information
  • The patient is pregnant, parturiente, or she breast-feeds
  • The patients having no wound
  • The patients diabetics having a wound chronicles of Rank 1 (Classification of the IWGDF) [IWGDF, Lipsky Clin Infect Dis on 2004]

结局指标

主要结局

dermal sample

时间窗: 36 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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