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