Clinical trial NCT03740646: Pneumocystis Primary Infection in Non-immunosuppressed Infants
Official title: Primary-Pneumocystis Infection: Pneumocystis Jirovecii Detection in Nasopharyngeal Aspirates From Symptomatic Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Diseases
Fever
Keywords: Bronchiolitis
Nasopharyngeal aspirates
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 400
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: symptomatic newborns and infants who underwent NPAs for microbiological diagnoses

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

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.

Eligibility 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

Primary outcomes:
measure: Pneumocystis presence or not in nasopharyngeal specimens from newborns and infants
timeFrame: At patient inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: Brest University Hospital, Brest, France
name: NEVEZ Gilles, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: