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NC: Granulomatous Pneumocystis Pneumonia

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT03731156
Collaborator
(none)
16
Enrollment
1
Location
19
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The intra-alveolar form of Pneumocystis jiroveci pneumonia (PjP) is a common pathology in immunocompromised patients, particularly those infected with HIV. The diagnosis is based on the detection of Pj in a LBA. Intra-tissue granulomatous form (PGP) is a rare entity observed in non-HIV immunocompromised patients. In this case, the LBA is mostly non-contributory and the diagnosis is based solely on the detection of cysts on histological examination on biopsy of a pulmonary nodule. For many years, it has been clearly demonstrated that the use of a specific PCR clearly improves the biological diagnosis of PcP. However, in case of granulomatous form this method is not implemented because the diagnostic hypothesis is not mentioned.

In 2018, two cases of PGP were diagnosed at 3-month intervals at Montpellier University Hospital Center. The diagnostic confirmation was obtained with PCR Pj. In this context the investigators will investigate the interest of implementing PCR Pj on biopsies on pulmonary nodules from hospitalized patients between 2015 and 2018. In all selected patients, histopathological aspect of the nodule was compatible with a PGP and, no other diagnosis has been confirmed (infectious, tumoral, inflammatory ...). Finally, 17 patients were selected to check retrospectively, if the presence of Pj could be at the origin of the pathology.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    16 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Biological Diagnosis of Granulomatous Pneumocystis Pneumonia
    Actual Study Start Date :
    Jun 1, 2018
    Actual Primary Completion Date :
    Dec 30, 2019
    Actual Study Completion Date :
    Dec 30, 2019

    Outcome Measures

    Primary Outcome Measures

    1. PCR results [1 day]

      PCR results

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • pulmonary nodule
    Exclusion Criteria:
    • nodule : tumoral, other infections than Pj, inflammatory

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uhmontpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Study Director: Laurence Lachaud, MD, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT03731156
    Other Study ID Numbers:
    • RECHMPL18_0422
    First Posted:
    Nov 6, 2018
    Last Update Posted:
    Mar 10, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    Granulomatous Pneumocystis Pneumonia
    PCR Pneumocystis jirovecii
    Additional relevant MeSH terms:
    Pneumonia
    Mycoses
    Pneumonia, Pneumocystis
    Invasive Fungal Infections
    Multiple Pulmonary Nodules

    Study Results

    No Results Posted as of Mar 10, 2020