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Specialized Proresolving Mediators in Pneumocystis Jirovecii Pneumonia (INFLA-PCP)

Primary Purpose

Pneumonia, Pneumocystis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
urine sampling
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pneumonia, Pneumocystis focused on measuring Pneumocystis jirovecii, Pneumonia, Specialized Proresolving Mediators, Inflammation, prognosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Exclusion Criteria:

  • individuals placed under juridical protection,
  • individuals placed under guardianship, or supervision.
  • Pregnancy or breastfeeding.

Sites / Locations

  • Institut Fédératif de Biologie (IFB), CHU - Hôpital Purpan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

pneumocystosis with favourable evolution

pneumocystosis with unfavourable outcome

Pneumocystis colonization

Arm Description

patients with a favourable pneumocystosis outcome

patients with unfavourable pneumocystosis outcome

subject colonized by Pneumocystis jirovecii

Outcomes

Primary Outcome Measures

14,15-DHET blood level at the inclusio
variation of 14,15-DHET blood level at inclusion between each group
14,15-DHET blood level
variation of 14,15-DHET blood level at day 7 between each group

Secondary Outcome Measures

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

Full Information

First Posted
July 19, 2018
Last Updated
February 28, 2022
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT03606252
Brief Title
Specialized Proresolving Mediators in Pneumocystis Jirovecii Pneumonia
Acronym
INFLA-PCP
Official Title
Specialized Proresolving Mediators Evaluation in Pneumocystis Pneumonia Human Infection : Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
March 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Pneumocystis
Keywords
Pneumocystis jirovecii, Pneumonia, Specialized Proresolving Mediators, Inflammation, prognosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pneumocystosis with favourable evolution
Arm Type
Other
Arm Description
patients with a favourable pneumocystosis outcome
Arm Title
pneumocystosis with unfavourable outcome
Arm Type
Other
Arm Description
patients with unfavourable pneumocystosis outcome
Arm Title
Pneumocystis colonization
Arm Type
Other
Arm Description
subject colonized by Pneumocystis jirovecii
Intervention Type
Other
Intervention Name(s)
Blood sampling
Intervention Description
6 blood sample, 3 at J0 and 3 at J7 ( 2 tubes EDTA of 7mL, 1 tube Blood RNA of 3 mL)
Intervention Type
Other
Intervention Name(s)
urine sampling
Intervention Description
2 urine sample (1 at J0 and 1 at J7)
Primary Outcome Measure Information:
Title
14,15-DHET blood level at the inclusio
Description
variation of 14,15-DHET blood level at inclusion between each group
Time Frame
Day 0
Title
14,15-DHET blood level
Description
variation of 14,15-DHET blood level at day 7 between each group
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
14,15-DHET urine level
Description
variation of 14,15-DHET urine level at inclusion ad day 7 between each group
Time Frame
Day 0 and Day 7
Title
Specialized Pro-Resolving Mediators in blood
Description
Specialized Pro-Resolving Mediators in blood at inclusion and day 7 between each group
Time Frame
Day 0 and Day 7
Title
Specialized Pro-Resolving Mediators in urine
Description
Specialized Pro-Resolving Mediators in urine at inclusion and day 7each between group
Time Frame
Day 0 and Day 7
Title
Expression levels of the SPM enzymes
Description
Expression levels of the enzymes implicated in SPM synthesis and catabolism in blood at D0 and day 7
Time Frame
Day 0 and day 7
Title
Inflammatory blood profile
Description
Inflammatory blood profile with composite criteria pro-inflammatory and anti-inflammatory cytokines levels measured by flow cytometry
Time Frame
Day 0 and day 7
Title
Immune cells profile
Description
immune cell proportions in blood measured by flow cytometry
Time Frame
Day 0 and day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine Berry, PHD
Organizational Affiliation
Toulouse University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Fédératif de Biologie (IFB), CHU - Hôpital Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24440053
Citation
Ko Y, Jeong BH, Park HY, Koh WJ, Suh GY, Chung MP, Kwon OJ, Jeon K. Outcomes of Pneumocystis pneumonia with respiratory failure in HIV-negative patients. J Crit Care. 2014 Jun;29(3):356-61. doi: 10.1016/j.jcrc.2013.12.005. Epub 2013 Dec 21.
Results Reference
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PubMed Identifier
23433532
Citation
Le Gal S, Robert-Gangneux F, Perrot M, Rouille A, Virmaux M, Damiani C, Totet A, Gangneux JP, Nevez G. Absence of Pneumocystis dihydropteroate synthase mutants in Brittany, France. Diagn Microbiol Infect Dis. 2013 May;76(1):113-5. doi: 10.1016/j.diagmicrobio.2013.01.018. Epub 2013 Feb 20.
Results Reference
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PubMed Identifier
23831705
Citation
Le Faouder P, Baillif V, Spreadbury I, Motta JP, Rousset P, Chene G, Guigne C, Terce F, Vanner S, Vergnolle N, Bertrand-Michel J, Dubourdeau M, Cenac N. LC-MS/MS method for rapid and concomitant quantification of pro-inflammatory and pro-resolving polyunsaturated fatty acid metabolites. J Chromatogr B Analyt Technol Biomed Life Sci. 2013 Aug 1;932:123-33. doi: 10.1016/j.jchromb.2013.06.014. Epub 2013 Jun 15.
Results Reference
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PubMed Identifier
27226306
Citation
Gilroy DW, Edin ML, De Maeyer RP, Bystrom J, Newson J, Lih FB, Stables M, Zeldin DC, Bishop-Bailey D. CYP450-derived oxylipins mediate inflammatory resolution. Proc Natl Acad Sci U S A. 2016 Jun 7;113(23):E3240-9. doi: 10.1073/pnas.1521453113. Epub 2016 May 25.
Results Reference
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PubMed Identifier
27349824
Citation
El Fane M, Sodqi M, Oulad Lahsen A, Chakib A, Marih L, Marhoum El Filali K. [Pneumocystosis during HIV infection]. Rev Pneumol Clin. 2016 Aug;72(4):248-54. doi: 10.1016/j.pneumo.2016.04.004. Epub 2016 Jun 24. French.
Results Reference
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PubMed Identifier
24696140
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.
Results Reference
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PubMed Identifier
29449599
Citation
Karsten E, Breen E, Herbert BR. Red blood cells are dynamic reservoirs of cytokines. Sci Rep. 2018 Feb 15;8(1):3101. doi: 10.1038/s41598-018-21387-w.
Results Reference
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PubMed Identifier
29588374
Citation
Keegan A, Charest K, Schmidt R, Briggs D, Deangelo DJ, Li B, Morgan EA, Pozdnyakova O. Flow cytometric minimal residual disease assessment of peripheral blood in acute lymphoblastic leukaemia patients has potential for early detection of relapsed extramedullary disease. J Clin Pathol. 2018 Jul;71(7):653-658. doi: 10.1136/jclinpath-2017-204828. Epub 2018 Mar 27.
Results Reference
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Specialized Proresolving Mediators in Pneumocystis Jirovecii Pneumonia

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