Clinical trial NCT03606252: Specialized Proresolving Mediators in Pneumocystis Jirovecii Pneumonia
Official title: Specialized Proresolving Mediators Evaluation in Pneumocystis Pneumonia Human Infection : Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia, Pneumocystis
Keywords: Pneumocystis jirovecii
Pneumonia
Specialized Proresolving Mediators
Inflammation
prognosis
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Eligibility criteria: 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.

Primary outcomes:
measure: 14,15-DHET blood level at the inclusio
timeFrame: Day 0
measure: 14,15-DHET blood level
timeFrame: Day 7
Secondary outcomes:
measure: 14,15-DHET urine level
timeFrame: Day 0 and Day 7
measure: Specialized Pro-Resolving Mediators in blood
timeFrame: Day 0 and Day 7
measure: Specialized Pro-Resolving Mediators in urine
timeFrame: Day 0 and Day 7
measure: Expression levels of the SPM enzymes
timeFrame: Day 0 and day 7
measure: Inflammatory blood profile
timeFrame: Day 0 and day 7
measure: Immune cells profile
timeFrame: Day 0 and day 7
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Institut Fédératif de Biologie (IFB), CHU - Hôpital Purpan
Study officials:
affiliation: University Hospital, Toulouse
name: Antoine Berry, PHD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Colas RA, Shinohara M, Dalli J, Chiang N, Serhan CN. Identification and signature profiles for pro-resolving and inflammatory lipid mediators in human tissue. Am J Physiol Cell Physiol. 2014 Jul 1;307(1):C39-54. doi: 10.1152/ajpcell.00024.2014. Epub 2014 Apr 2.
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