Pneumocystis Primary Infection in Non-immunosuppressed Infants (CAPRI-PC)

Primary-Pneumocystis Infection: Pneumocystis Jirovecii Detection in Nasopharyngeal Aspirates From Symptomatic Infants

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

Study Overview

• Status: Completed
• Conditions: Fever; Pulmonary Diseases

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 Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHRU de Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

symptomatic newborns and infants who underwent NPAs for microbiological diagnoses

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pneumocystis presence or not in nasopharyngeal specimens from newborns and infants	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.	At patient inclusion

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2019
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: November 13, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Bronchiolitis; Nasopharyngeal aspirates
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Bacterial Infections and Mycoses; Mycoses; Lung Diseases, Fungal; Pneumocystis Infections; Pneumonia, Pneumocystis
• Other Study ID Numbers: CAPRI-PC( 29BRC18.0052)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No