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

Toulouse University Hospital

Status: Completed

Conditions: Pneumonia, Pneumocystis

Treatments: Other: urine sampling; Other: Blood sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT03606252

2018-A01062-53 (Other Identifier)

RC31/18/0098

Details and patient eligibility

About

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.

Full 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

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

66 participants in 3 patient groups

pneumocystosis with favourable evolution

Other group

Description:

patients with a favourable pneumocystosis outcome

Treatment:

Other: Blood sampling

Other: urine sampling

pneumocystosis with unfavourable outcome

Other group

Description:

patients with unfavourable pneumocystosis outcome

Treatment:

Other: Blood sampling

Other: urine sampling

Pneumocystis colonization

Other group

Description:

subject colonized by Pneumocystis jirovecii

Treatment:

Other: Blood sampling

Other: urine sampling