Specialized Proresolving Mediators in Pneumocystis Jirovecii Pneumonia

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Pneumonia, Pneumocystis

Intervention / Treatment
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* Other: Blood sampling
* Other: urine sampling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: pneumocystosis with favourable evolution<br>patients with a favourable pneumocystosis outcome | Other: Blood sampling<br>* 6 blood sample, 3 at J0 and 3 at J7 ( 2 tubes EDTA of 7mL, 1 tube Blood RNA of 3 mL)<br>Other: urine sampling<br>* 2 urine sample (1 at J0 and 1 at J7)<br>|
| Other: pneumocystosis with unfavourable outcome<br>patients with unfavourable pneumocystosis outcome | Other: Blood sampling<br>* 6 blood sample, 3 at J0 and 3 at J7 ( 2 tubes EDTA of 7mL, 1 tube Blood RNA of 3 mL)<br>Other: urine sampling<br>* 2 urine sample (1 at J0 and 1 at J7)<br>|
| Other: Pneumocystis colonization<br>subject colonized by Pneumocystis jirovecii | Other: Blood sampling<br>* 6 blood sample, 3 at J0 and 3 at J7 ( 2 tubes EDTA of 7mL, 1 tube Blood RNA of 3 mL)<br>Other: urine sampling<br>* 2 urine sample (1 at J0 and 1 at J7)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 14,15-DHET blood level at the inclusio | variation of 14,15-DHET blood level at inclusion between each group | Day 0 | 
| 14,15-DHET blood level | variation of 14,15-DHET blood level at day 7 between each group | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 14,15-DHET urine level | variation of 14,15-DHET urine level at inclusion ad day 7 between each group | Day 0 and Day 7 | 
| Specialized Pro-Resolving Mediators in blood | Specialized Pro-Resolving Mediators in blood at inclusion and day 7 between each group | Day 0 and Day 7 | 
| Specialized Pro-Resolving Mediators in urine | Specialized Pro-Resolving Mediators in urine at inclusion and day 7each between group | Day 0 and Day 7 | 
| Expression levels of the SPM enzymes | Expression levels of the enzymes implicated in SPM synthesis and catabolism in blood at D0 and day 7 | Day 0 and day 7 | 
| Inflammatory blood profile | Inflammatory blood profile with composite criteria pro-inflammatory and anti-inflammatory cytokines levels measured by flow cytometry | Day 0 and day 7 | 
| Immune cells profile | immune cell proportions in blood measured by flow cytometry | Day 0 and day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumocystis jirovecii, Pneumonia, Specialized Proresolving Mediators, Inflammation, prognosis