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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03731156
Other study ID # RECHMPL18_0422
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2018
Est. completion date December 30, 2019

Study information

Verified date March 2020
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date December 30, 2019
Est. primary completion date December 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- pulmonary nodule

Exclusion Criteria:

- nodule : tumoral, other infections than Pj, inflammatory

Study Design


Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary PCR results PCR results 1 day
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