Pneumocystis Primary Infection in Non-immunosuppressed Infants

Fever Clinical Trial

— CAPRI-PC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03740646
• Other study ID #: CAPRI-PC( 29BRC18.0052)
• Status: Completed
• Start date: January 21, 2019
• Est. completion date: May 31, 2021

Study information

• Verified date: September 2021
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Fever
• Pneumonia, Pneumocystis
• Pulmonary Diseases

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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