跳至主要内容
临床试验/NCT03498963
NCT03498963已完成不适用

Early Detection by Molecular Biology Technique of Pathogens Responsible for Respiratory Infections Associated With Drownings in Seawater: Pilot Study at the CHU de Nice

Centre Hospitalier Universitaire de Nice4 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2019年9月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
4
主要终点
presence of potentially pathogenic seawater germs not detected by standard cultures and found in the drowning environment.

研究概览

简要总结

Little data is currently available on the type of pathogen responsible for respiratory infections following drowning. Many environmental germs present in seawater are described as difficult to culture on standard media but are potentially pathogenic. Even using specific culture media nearly 90% of the bacteria present in the water remain non-cultivable. The use of 16S and 18S rDNA amplification followed by high throughput sequencing on respiratory samples could allow us to objectify these bacteria potentially involved in the physiopathological process secondary to drowning and thus improve their overall management.

Carrying out a bronchoalveolar lavage (BAL) within 24 hours after admission to intensive care with analysis on standard and specific culture media of environmental germs, carrying out antibiograms, DNA extraction, amplification by universal 16 and 18S rDNA primers followed by high flow sequencing and phylogenetic analysis of pathogens found. Comparison of these results with the same analyses performed on seawater samples taken near the drowning site and during a new AML at 72h for patients still intubated and showing signs of pneumonia in order to determine if the pathogens detected at the entrance persist and are present in the environment.

AML at the patient's entrance, on day 3 and environmental sampling in the drowning environment within 24 hours. Standard and specific bacteriological analyses with molecular biology techniques (amplification 16 and 18S rDNA) carried out at Pr RUIMY's laboratory (Nice University Hospital) sequencing on INRA's Toulouse genomics platform. Phylogenetic data capture and analysis at IRCAN (Bioinformatics, Croce Olivier). Patient follow-up until resuscitation discharge.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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

  • adult patient
  • hospitalized in intensive care for severe drowning in sea water (Spilzman stage 5 or 6) (4)
  • intubated within 24 hours of admission or before admission to intensive care
  • affiliated to social security

排除标准

  • patients under guardianship, trusteeship or detention

结局指标

主要结局

presence of potentially pathogenic seawater germs not detected by standard cultures and found in the drowning environment.

时间窗: 3 days

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 (4)

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