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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

Tracking Information
First Submitted Date November 8, 2018
First Posted Date November 14, 2018
Last Update Posted Date July 9, 2019
Actual Study Start Date January 1, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 13, 2018)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pneumocystis Primary Infection in Non-immunosuppressed Infants
Official Title Primary-Pneumocystis Infection: Pneumocystis Jirovecii Detection in Nasopharyngeal Aspirates From Symptomatic Infants
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Nasopharyngeal aspirates with or without Pneumocystis
Sampling Method Non-Probability Sample
Study Population symptomatic newborns and infants who underwent NPAs for microbiological diagnoses
Condition
  • Pulmonary Diseases
  • Fever
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 13, 2018)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 12 Months   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: NEVEZ Gilles, MD PhD 02-98145091 gilles.nevez@chu-brest.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03740646
Other Study ID Numbers CAPRI-PC( 29BRC18.0052)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Brest
Study Sponsor University Hospital, Brest
Collaborators Not Provided
Investigators
Principal Investigator: NEVEZ Gilles, MD PhD Brest University Hospital, Brest, France
PRS Account University Hospital, Brest
Verification Date July 2019