NCT03740646

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 21, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

September 8, 2021

Status Verified

September 1, 2021

Enrollment Period

2.4 years

First QC Date

November 8, 2018

Last Update Submit

September 7, 2021

Conditions

Pulmonary DiseasesFever

Keywords

BronchiolitisNasopharyngeal aspirates

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

AgeUp to 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

symptomatic newborns and infants who underwent NPAs for microbiological diagnoses

You may qualify if:

  • symptomatic newborns and infants who underwent NPAs for microbiological diagnoses

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasopharyngeal aspirates with or without Pneumocystis

MeSH Terms

Conditions

Lung DiseasesFeverBronchiolitis

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsBronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesLung Diseases, Obstructive

Study Officials

  • NEVEZ Gilles, MD PhD

    Brest University Hospital, Brest, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2018

First Posted

November 14, 2018

Study Start

January 21, 2019

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

September 8, 2021

Record last verified: 2021-09

Locations

FR(1)