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CAPRI-PC: Pneumocystis Primary Infection in Non-immunosuppressed Infants

Sponsor
University Hospital, Brest (Other)
Overall Status
Completed
CT.gov ID
NCT03740646
Collaborator
(none)
400
Enrollment
1
Location
28.3
Actual Duration (Months)
14.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine the prevalence of P. jirovecii in nasopharyngeal aspirations of neonates and infants hospitalized for symptomatic respiratory infection.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    It is recognized that primary infection with Pneumocystis, an opportunistic and transmissible fungus, occurs early in childhood. Early investigations of primary infection considering the detection of P. jirovecii in respiratory specimens suggests that primary infection in infants without immunodeficiency could be either asymptomatic or symptomatic. The infection may be identified as an apparently benign respiratory infection evolving on its own, but may also be contemporaneous with another viral or bacterial respiratory infection. In addition, there are little data available on the genotypic characteristics of P. jirovecii in infants developing primary infection.

    In this context, the project will focus on the detection of P. jirovecii in hospitalized infants, presented with symptoms, and without overt immunodeficiency. The prospective collection of biological, clinical and epidemiological data in these infants will make it possible to identify risk factors for the acquisition of the fungus and to address its role in symptoms and clinical presentation. A second focus will be on the identification and comparison of genotypes in infants developing primary infection and in immunocompromised adults developing PPC or colonized by the fungus. These two approaches are the necessary steps to address the putative role of these patient populations (infants and adults) in the human reservoir of the fungus. A third focus will be the detection and genotypic identification of P. jirovecii in infants and the exhaled air of infants in their environment. The potential role of infants as potential infectious sources may be determined.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Primary-Pneumocystis Infection: Pneumocystis Jirovecii Detection in Nasopharyngeal Aspirates From Symptomatic Infants
    Actual Study Start Date :
    Jan 21, 2019
    Actual Primary Completion Date :
    May 31, 2021
    Actual Study Completion Date :
    May 31, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Pneumocystis presence or not in nasopharyngeal specimens from newborns and infants [At patient inclusion]

      The main biological parameter which will be measured will be the positive or negative result of P. jirovecii detection in nasopharyngeal apsirate specimens from non-immunosuppressed newborns and infants. The prevalence of P. jirovecii comtemporary with first contacts with the fungus will be assessed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 12 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • symptomatic newborns and infants who underwent NPAs for microbiological diagnoses
    Exclusion Criteria:
    • asymptomatic newborns and infants, newborns and infants who did not undergo NPAs, infants > 12 months or children > 2 years; newborns and infants whose parents did not accept to participate

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU de Brest Brest France 29609

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    • Principal Investigator: NEVEZ Gilles, MD PhD, Brest University Hospital, Brest, France

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT03740646
    Other Study ID Numbers:
    • CAPRI-PC( 29BRC18.0052)
    First Posted:
    Nov 14, 2018
    Last Update Posted:
    Sep 8, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Brest
    Bronchiolitis
    Nasopharyngeal aspirates
    Additional relevant MeSH terms:
    Pneumonia, Pneumocystis

    Study Results

    No Results Posted as of Sep 8, 2021