Clinical and Microbiological Impact of Respiratory Viral Infections in the Short and Medium Term in Infants (<24 Months) With Cystic Fibrosis.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- Number of Respiratory Viral Infection
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- — to 24 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)