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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Toulouse

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 12, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 12, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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