NCT03606252

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2020

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

1.4 years

First QC Date

July 19, 2018

Last Update Submit

February 28, 2022

Conditions

Pneumonia, Pneumocystis

Keywords

Pneumocystis jiroveciiPneumoniaSpecialized Proresolving MediatorsInflammationprognosis

Outcome Measures

Primary Outcomes (2)

  • 14,15-DHET blood level at the inclusio

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

    Day 0

  • 14,15-DHET blood level

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

    Day 7

Secondary Outcomes (6)

  • 14,15-DHET urine level

    Day 0 and Day 7

  • Specialized Pro-Resolving Mediators in blood

    Day 0 and Day 7

  • Specialized Pro-Resolving Mediators in urine

    Day 0 and Day 7

  • Expression levels of the SPM enzymes

    Day 0 and day 7

  • Inflammatory blood profile

    Day 0 and day 7

  • +1 more secondary outcomes

Study Arms (3)

pneumocystosis with favourable evolution

OTHER

patients with a favourable pneumocystosis outcome

Other: Blood samplingOther: urine sampling

pneumocystosis with unfavourable outcome

OTHER

patients with unfavourable pneumocystosis outcome

Other: Blood samplingOther: urine sampling

Pneumocystis colonization

OTHER

subject colonized by Pneumocystis jirovecii

Other: Blood samplingOther: urine sampling

Interventions

Blood samplingOTHER

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

Pneumocystis colonizationpneumocystosis with favourable evolutionpneumocystosis with unfavourable outcome
urine samplingOTHER

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

Pneumocystis colonizationpneumocystosis with favourable evolutionpneumocystosis with unfavourable outcome

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Toulouse, 31059, France

Location

Related Publications (8)

  • 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.

    PMID: 24440053BACKGROUND

  • 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.

    PMID: 23433532BACKGROUND

  • 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.

    PMID: 23831705BACKGROUND

  • 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.

    PMID: 27226306BACKGROUND

  • 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.

    PMID: 27349824BACKGROUND

  • 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.

    PMID: 24696140BACKGROUND

  • 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.

    PMID: 29449599BACKGROUND

  • 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.

    PMID: 29588374BACKGROUND

MeSH Terms

Conditions

Pneumonia, PneumocystisPneumoniaInflammation

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lung Diseases, FungalMycosesBacterial Infections and MycosesInfectionsPneumocystis InfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Antoine Berry, PHD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2018

First Posted

July 30, 2018

Study Start

October 1, 2018

Primary Completion

March 12, 2020

Study Completion

March 12, 2020

Last Updated

March 2, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)