Impact of Respiratory Viral Infections in Infants With Cystic Fibrosis. (PREVIMUC)

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

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 Overview

• Status: Completed
• Conditions: Cystic Fibrosis; Respiratory Viral Infection
• Intervention / Treatment: Other: Physical assessment

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- infant <24 months with cystic fibrosis

Exclusion Criteria:

- patient >24 months

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: cystic fibrosis infants; 1 year follow-up in CF infants	Other: Physical assessment; 1 year follow-up in CF infants with clinical, microbiological and therapeutic assessments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Respiratory Viral Infection	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of respiratory viruses in throat-swabs	A panel of 10 viruses will be tested using polymerase chain reaction (PCR) and RT-PCR technology.	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
Identification of bacterial flora in throat-swabs		up to 12 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Stéphanie VRIELYNCK, MD, Cystic Fibrosis Pediatric Reference Centrer, Hospices Civils de Lyon, 69677 Bron Cedex, France

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: July 25, 2016
• First Submitted That Met QC Criteria: July 25, 2016
• First Posted (Estimate): July 28, 2016

Study Record Updates

• Last Update Posted (Estimate): July 28, 2016
• Last Update Submitted That Met QC Criteria: July 25, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: children; cystic fibrosis; viruses; respiratory viral infection
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Infections; Communicable Diseases; Virus Diseases; Cystic Fibrosis
• Other Study ID Numbers: 69HCL14_0276