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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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

Condition or disease
Pulmonary Diseases Fever

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.


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Study Type : Observational
Estimated 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 : January 1, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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
Nasopharyngeal aspirates with or without Pneumocystis


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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
symptomatic newborns and infants who underwent NPAs for microbiological diagnoses
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: NEVEZ Gilles, MD PhD 02-98145091 gilles.nevez@chu-brest.fr

Locations
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France
CHRU de Brest Recruiting
Brest, France, 29609
Contact: CROS Pierrick       pierrick.cros@chu-brest.fr   
Sub-Investigator: ROUE Jean-Michel         
Sub-Investigator: DE PARSCAU Loïc         
Sub-Investigator: SIZUN Jacques         
Sponsors and Collaborators
University Hospital, Brest
Investigators
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Principal Investigator: NEVEZ Gilles, MD PhD Brest University Hospital, Brest, France

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03740646     History of Changes
Other Study ID Numbers: CAPRI-PC( 29BRC18.0052)
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019

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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:
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Lung Diseases
Pneumonia, Pneumocystis
Respiratory Tract Diseases
Lung Diseases, Fungal
Mycoses
Pneumocystis Infections
Pneumonia
Respiratory Tract Infections