INFLA-PCP: Specialized Proresolving Mediators in Pneumocystis Jirovecii Pneumonia

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Completed

CT.gov ID

NCT03606252

Collaborator

(none)

Enrollment

Location

Arms

17.3

Actual Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia, Pneumocystis	Other: Blood sampling Other: urine sampling	N/A

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

Actual Enrollment :

66 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Oct 1, 2018

Actual Primary Completion Date :

Mar 12, 2020

Actual Study Completion Date :

Mar 12, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Other: pneumocystosis with favourable evolution

patients with a favourable pneumocystosis outcome

Other: Blood sampling

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

Other: urine sampling

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

Other: pneumocystosis with unfavourable outcome

patients with unfavourable pneumocystosis outcome

Other: Blood sampling

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

Other: urine sampling

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

Other: Pneumocystis colonization

subject colonized by Pneumocystis jirovecii

Other: Blood sampling

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

Other: urine sampling

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

Outcome Measures

Primary Outcome Measures

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

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
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
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
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
Immune cells profile [Day 0 and day 7]
immune cell proportions in blood measured by flow cytometry

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).