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Completed

NCT Number: NCT03606252

Specialized Proresolving Mediators in Pneumocystis Jirovecii Pneumonia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Toulouse, 31059, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sampling

Other

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

Urine sampling

Other

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

Primary outcomes

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

    Time frame: Day 0

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

  2. 14,15-DHET blood level

    Time frame: Day 7

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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Immune cells profile

    Time frame: Day 0 and day 7

    immune cell proportions in blood measured by flow cytometry

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: INFLA-PCP

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 30, 2018
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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