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临床试验/NCT03606252
NCT03606252已完成不适用

Specialized Proresolving Mediators Evaluation in Pneumocystis Pneumonia Human Infection : Pilot Study.

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2018年10月1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
66
试验地点
2
主要终点
14,15-DHET blood level at the inclusio

研究概览

简要总结

This study aims to evaluate specialized proresolving mediators (SPM) concentrations for the first time in subjects infected with Pneumocystis jirovecii. SPM will be measured in blood and urine in patients with favourable or unfavourable outcome of Pneumocystis pneumonia and in patients colonized by Pneumocystis jirovecii. The hypothesis is that low levels of SPM in the blood could be predictive of a negative outcome of pneumocystosis.

详细描述

Pneumocystis pneumonia is a severe fungal disease threatening immunosuppressed subjects such as patients suffering from AIDS, oncohematological diseases or solid organ transplanted patients. The disease is characterized by an important inflammation in the infected lungs which is mainly responsible for lungs lesions. Despite an adequate treatment introduction, mortality is still around 20% which can not be explained by a treatment resistance. Specialized proresolving mediators (SPM), including lipoxins, maresins, protectins and resolvins, are newly described molecules implicated in the active process of inflammation resolution. The investigators hypothesis in this study is that high levels of SPM could be predictive of a good resolution of the harmful inflammation, thus a good evolution of the disease, in adequate pneumocystosis therapy conditions. On the contrary, low levels of SPM could be predictive of an unfavourable outcome despite a treatment targeting Pneumocystis jirovecii

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

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

  • Patient over 18 years old
  • Patient with a social security cover.
  • Free and informed oral consent given.
  • Pneumocystis infection or colonization diagnosed on BAL (Broncho-alveolar liquid) or sputum at Toulouse University hospital Mycology laboratory.
  • Adequate Pneumocystis therapy for infected patients (cotrimoxazole).

排除标准

  • individuals placed under juridical protection,
  • individuals placed under guardianship, or supervision.
  • Pregnancy or breastfeeding.

结局指标

主要结局

14,15-DHET blood level at the inclusio

时间窗: Day 0

variation of 14,15-DHET blood level at inclusion between each group

14,15-DHET blood level

时间窗: Day 7

variation of 14,15-DHET blood level at day 7 between each group

次要结局

  • Inflammatory blood profile(Day 0 and day 7)
  • Immune cells profile(Day 0 and day 7)
  • Specialized Pro-Resolving Mediators in blood(Day 0 and Day 7)
  • Specialized Pro-Resolving Mediators in urine(Day 0 and Day 7)
  • Expression levels of the SPM enzymes(Day 0 and day 7)
  • 14,15-DHET urine level(Day 0 and Day 7)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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