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Specialized Proresolving Mediators in Pneumocystis Jirovecii Pneumonia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03606252
Acronym
INFLA-PCP
Enrollment
66
Registered
2018-07-30
Start date
2018-10-01
Completion date
2020-03-12
Last updated
2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia, Pneumocystis

Keywords

Pneumocystis jirovecii, Pneumonia, Specialized Proresolving Mediators, Inflammation, prognosis

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

Interventions

OTHERBlood sampling

6 blood sample, 3 at J0 and 3 at J7 ( 2 tubes EDTA of 7mL, 1 tube Blood RNA of 3 mL)

2 urine sample (1 at J0 and 1 at J7)

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
14,15-DHET blood level at the inclusioDay 0variation of 14,15-DHET blood level at inclusion between each group
14,15-DHET blood levelDay 7variation of 14,15-DHET blood level at day 7 between each group

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026