Impact of Respiratory Viral Infections in Infants With Cystic Fibrosis.

NCT02847156 | Completed

• 1 other identifier: 69HCL14_0276
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis; Respiratory Viral Infection

Keywords

cystic fibrosis; viruses; respiratory viral infection; children

Outcome Measures

Primary Outcomes (1)

• Number of Respiratory Viral Infection

  up to 12 months

Secondary Outcomes (6)

• Identification of respiratory viruses in throat-swabs

  up to 12 months

• Number of antibiotics treatments (oral or IV)

  up to 12 months

• Number of bronchodilator administrations

  up to 12 months

• Number of corticosteroids administrations

  up to 12 months

• Number of hospitalization or hospital admission due to upper or lower RVI

  up to 12 months

Study Arms (1)

cystic fibrosis infants

OTHER

1 year follow-up in CF infants

Other: Physical assessment

Interventions

Physical assessment OTHER

1 year follow-up in CF infants with clinical, microbiological and therapeutic assessments

cystic fibrosis infants

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- infant \<24 months with cystic fibrosis

You may not qualify if:

• \- patient \>24 months

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Cystic Fibrosis Pediatric Reference Centrer, Hospices Civils de Lyon

Bron, 69677, France

Location

MeSH Terms

Conditions

Cystic Fibrosis; Virus Diseases

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Infections

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Stéphanie VRIELYNCK, MD

  Cystic Fibrosis Pediatric Reference Centrer, Hospices Civils de Lyon, 69677 Bron Cedex, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: July 28, 2016
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: July 28, 2016

Record last verified: 2016-07

Locations

FR (1)