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Pneumonia, PneumocystisINFLA-PCPNCT03606252

Specialized Proresolving Mediators in Pneumocystis Jirovecii Pneumonia

A study testing Blood sampling and urine sampling in people with Pneumonia, Pneumocystis, run by University Hospital, Toulouse at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pneumonia, Pneumocystis
What is being tested?
Blood sampling and urine sampling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteFrance
Study dates
1 Oct 2018to 12 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

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

    Toulouse, 31059

Other trials in France

About this study

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

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

Being tested
Blood sampling, urine sampling
Keywords
Pneumocystis jirovecii, Pneumonia, Specialized Proresolving Mediators, Inflammation, prognosis
Medical subject headings
Pneumonia, Pneumocystis, Pneumonia, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood samplingOther

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

  • urine samplingOther

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

Study groups in NCT03606252
Study groupRoleWhat they receive
pneumocystosis with favourable evolutionOtherpatients with a favourable pneumocystosis outcome
Receives: Other: Blood sampling; Other: urine sampling
pneumocystosis with unfavourable outcomeOtherpatients with unfavourable pneumocystosis outcome
Receives: Other: Blood sampling; Other: urine sampling
Pneumocystis colonizationOthersubject colonized by Pneumocystis jirovecii
Receives: Other: Blood sampling; Other: urine sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Day 0

  2. 14,15-DHET blood level

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

    Measured: Day 7

Secondary outcomes (6)

  1. 14,15-DHET urine level

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Day 0 and day 7

  6. Immune cells profile

    immune cell proportions in blood measured by flow cytometry

    Measured: Day 0 and day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2018
  2. Study start1 Oct 2018
  3. Primary completion12 Mar 2020
  4. Study completion12 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03606252
Sponsor's protocol ID
RC31/18/0098
Other IDs
2018-A01062-53
Acronym
INFLA-PCP
Status last verified
Feb 2022
First submitted
19 Jul 2018
Last updated
2 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Blood sampling and urine sampling in people with Pneumonia, Pneumocystis, run by University Hospital, Toulouse at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

14,15-DHET blood level at the inclusio (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03606252, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.

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