Specialized Proresolving Mediators in Pneumocystis Jirovecii Pneumonia

Not Applicable

Completed

• Conditions: Pneumonia, Pneumocystis
• Interventions: Other: Blood sampling; Other: urine sampling

• Registration Number: NCT03606252
• Lead Sponsor: University Hospital, Toulouse

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 Timeline

• Study First Submitted: 2018-07-19
• Study First Submitted QC: 2018-07-27
• Study First Posted: 2018-07-30
• Study Start: 2018-10-01
• Primary Completion: 2020-03-12
• Study Completion: 2020-03-12
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pneumocystosis with favourable evolution	Blood sampling	patients with a favourable pneumocystosis outcome
pneumocystosis with unfavourable outcome	Blood sampling	patients with unfavourable pneumocystosis outcome
Pneumocystis colonization	Blood sampling	subject colonized by Pneumocystis jirovecii
pneumocystosis with favourable evolution	urine sampling	patients with a favourable pneumocystosis outcome
pneumocystosis with unfavourable outcome	urine sampling	patients with unfavourable pneumocystosis outcome
Pneumocystis colonization	urine sampling	subject colonized by Pneumocystis jirovecii

Primary Outcome Measures

Name	Time	Method
14,15-DHET blood level at the inclusio	Day 0	variation of 14,15-DHET blood level at inclusion between each group
14,15-DHET blood level	Day 7	variation of 14,15-DHET blood level at day 7 between each group

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institut Fédératif de Biologie (IFB), CHU - Hôpital Purpan; 🇫🇷 Toulouse, France