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

February 28, 2022 updated by: University Hospital, Toulouse

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
14,15-DHET blood level at the inclusio
Time Frame: Day 0
variation of 14,15-DHET blood level at inclusion between each group
Day 0
14,15-DHET blood level
Time Frame: Day 7
variation of 14,15-DHET blood level at day 7 between each group
Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
14,15-DHET urine level
Time Frame: Day 0 and Day 7
variation of 14,15-DHET urine level at inclusion ad day 7 between each group
Day 0 and Day 7
Specialized Pro-Resolving Mediators in blood
Time Frame: Day 0 and Day 7
Specialized Pro-Resolving Mediators in blood at inclusion and day 7 between each group
Day 0 and Day 7
Specialized Pro-Resolving Mediators in urine
Time Frame: Day 0 and Day 7
Specialized Pro-Resolving Mediators in urine at inclusion and day 7each between group
Day 0 and Day 7
Expression levels of the SPM enzymes
Time Frame: Day 0 and day 7
Expression levels of the enzymes implicated in SPM synthesis and catabolism in blood at D0 and day 7
Day 0 and day 7
Inflammatory blood profile
Time Frame: Day 0 and day 7
Inflammatory blood profile with composite criteria pro-inflammatory and anti-inflammatory cytokines levels measured by flow cytometry
Day 0 and day 7
Immune cells profile
Time Frame: Day 0 and day 7
immune cell proportions in blood measured by flow cytometry
Day 0 and day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Antoine Berry, PHD, Toulouse University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

March 12, 2020

Study Completion (Actual)

March 12, 2020

Study Registration Dates

First Submitted

July 19, 2018

First Submitted That Met QC Criteria

July 27, 2018

First Posted (Actual)

July 30, 2018

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 28, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/18/0098
  • 2018-A01062-53 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pneumonia, Pneumocystis

Clinical Trials on Blood sampling

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe