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CompletedNCT03606252INFLA-PCPUpdated Mar 2, 2022

Specialized Proresolving Mediators in Pneumocystis Jirovecii Pneumonia

An interventional study of Blood sampling and urine sampling in Pneumonia, Pneumocystis, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-02.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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

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Conditions studied

  • Pneumonia, Pneumocystis

Keywords

  • Pneumocystis jirovecii
  • Pneumonia
  • Specialized Proresolving Mediators
  • Inflammation
  • prognosis
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In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 66 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
66 participants (actual)

Study arms

  • Other
    pneumocystosis with favourable evolution

    patients with a favourable pneumocystosis outcome

    Other: Blood sampling · Other: urine sampling

  • Other
    pneumocystosis with unfavourable outcome

    patients with unfavourable pneumocystosis outcome

    Other: Blood sampling · Other: urine sampling

  • Other
    Pneumocystis colonization

    subject colonized by Pneumocystis jirovecii

    Other: Blood sampling · Other: urine sampling

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)

  • Otherurine sampling

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

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What researchers measure

Primary outcomes

  1. 14,15-DHET blood level at the inclusio

    variation of 14,15-DHET blood level at inclusion between each group

    Time frame: Day 0

  2. 14,15-DHET blood level

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

    Time frame: Day 7

Secondary outcomes

  1. 14,15-DHET urine level

    variation of 14,15-DHET urine level at inclusion ad day 7 between each group

    Time frame: Day 0 and Day 7

  2. Specialized Pro-Resolving Mediators in blood

    Specialized Pro-Resolving Mediators in blood at inclusion and day 7 between each group

    Time frame: Day 0 and Day 7

  3. Specialized Pro-Resolving Mediators in urine

    Specialized Pro-Resolving Mediators in urine at inclusion and day 7each between group

    Time frame: Day 0 and Day 7

  4. Expression levels of the SPM enzymes

    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

  5. Inflammatory blood profile

    Inflammatory blood profile with composite criteria pro-inflammatory and anti-inflammatory cytokines levels measured by flow cytometry

    Time frame: Day 0 and day 7

  6. Immune cells profile

    immune cell proportions in blood measured by flow cytometry

    Time frame: Day 0 and day 7

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Study locations

1 site
  • Institut Fédératif de Biologie (IFB), CHU - Hôpital Purpan
    Toulouse, 31059, France
08

References and documents

Publications

  • 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. PubMed 24440053 ↗
  • 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. PubMed 23433532 ↗
  • 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. PubMed 23831705 ↗
  • 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. PubMed 27226306 ↗
  • 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. PubMed 27349824 ↗
  • 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. PubMed 24696140 ↗
  • 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. PubMed 29449599 ↗
  • 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. PubMed 29588374 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03606252
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Jul 30, 2018
Start date
Oct 1, 2018
Primary completion
Mar 12, 2020
Completion
Mar 12, 2020
Last update
Mar 2, 2022

Study contacts

Antoine Berry, PHD
principal investigator · Toulouse University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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