Pneumocystis Primary Infection in Non-immunosuppressed Infants (CAPRI-PC)
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|ClinicalTrials.gov Identifier: NCT03740646|
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : July 9, 2019
|Condition or disease|
|Pulmonary Diseases Fever|
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 Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Primary-Pneumocystis Infection: Pneumocystis Jirovecii Detection in Nasopharyngeal Aspirates From Symptomatic Infants|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
- Pneumocystis presence or not in nasopharyngeal specimens from newborns and infants [ Time Frame: 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.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740646
|Contact: NEVEZ Gilles, MD PhDfirstname.lastname@example.org|
|CHRU de Brest||Recruiting|
|Brest, France, 29609|
|Contact: CROS Pierrick email@example.com|
|Sub-Investigator: ROUE Jean-Michel|
|Sub-Investigator: DE PARSCAU Loïc|
|Sub-Investigator: SIZUN Jacques|
|Principal Investigator:||NEVEZ Gilles, MD PhD||Brest University Hospital, Brest, France|