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Clinical Trials/NCT02847156
NCT02847156
Completed
Not Applicable

Clinical and Microbiological Impact of Respiratory Viral Infections in the Short and Medium Term in Infants (<24 Months) With Cystic Fibrosis.

Hospices Civils de Lyon1 site in 1 country25 target enrollmentJanuary 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cystic Fibrosis
Sponsor
Hospices Civils de Lyon
Enrollment
25
Locations
1
Primary Endpoint
Number of Respiratory Viral Infection
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Respiratory Viral Infections (RVI) are particularly frequent in young children. Old data mention the deleterious role of some viruses such as the Respiratory Syncytial Virus in young children with cystic fibrosis (CF). However, recent epidemiological data on RVI in CF children are rare and the impact of most frequent viruses such as human rhinoviruses is usually not correctly evaluated.

The aim of this study is to assess the frequency of lower and upper RVI during a 1 year follow-up in CF infants and to evaluate the impact of RVI at a clinical, microbiological and therapeutic level.

Our hypothesis is that frequent and/or clinically severe RVIs have the worst impact in the short term and without any particular link with a specific virus as previously described.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
January 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • infant \<24 months with cystic fibrosis

Exclusion Criteria

  • patient \>24 months

Outcomes

Primary Outcomes

Number of Respiratory Viral Infection

Time Frame: up to 12 months

Secondary Outcomes

  • Number of hospitalization or hospital admission due to upper or lower RVI(up to 12 months)
  • Identification of respiratory viruses in throat-swabs(up to 12 months)
  • Number of corticosteroids administrations(up to 12 months)
  • Number of antibiotics treatments (oral or IV)(up to 12 months)
  • Number of bronchodilator administrations(up to 12 months)
  • Identification of bacterial flora in throat-swabs(up to 12 months)

Study Sites (1)

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