Impact of Respiratory Viral Infections in Infants With Cystic Fibrosis.

Not Applicable

Completed

• Conditions: Cystic Fibrosis; Respiratory Viral Infection
• Interventions: Other: Physical assessment

• Registration Number: NCT02847156
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-07
• Study First Submitted: 2016-07-25
• Study First Submitted QC: 2016-07-25
• Last Update Submitted: 2016-07-25
• Study First Posted: 2016-07-28
• Last Update Posted: 2016-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• infant <24 months with cystic fibrosis

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Exclusion Criteria

• patient >24 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cystic fibrosis infants	Physical assessment	1 year follow-up in CF infants

Primary Outcome Measures

Name	Time	Method
Number of Respiratory Viral Infection	up to 12 months

Secondary Outcome Measures

Name	Time	Method
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	A panel of 10 viruses will be tested using polymerase chain reaction (PCR) and RT-PCR technology.
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

Trial Locations

Locations (1)

Cystic Fibrosis Pediatric Reference Centrer, Hospices Civils de Lyon; 🇫🇷 Bron, France