Specialized Proresolving Mediators Evaluation in Pneumocystis Pneumonia Human Infection : Pilot Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 66
- Locations
- 2
- Primary Endpoint
- 14,15-DHET blood level at the inclusio
Study Overview
Brief Summary
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.
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •individuals placed under juridical protection,
- •individuals placed under guardianship, or supervision.
- •Pregnancy or breastfeeding.
Outcomes
Primary Outcomes
14,15-DHET blood level at the inclusio
Time Frame: Day 0
variation of 14,15-DHET blood level at inclusion between each group
14,15-DHET blood level
Time Frame: Day 7
variation of 14,15-DHET blood level at day 7 between each group
Secondary Outcomes
- 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)