Impact of Respiratory Viral Infections in Infants With Cystic Fibrosis.

Cystic Fibrosis Clinical Trial

— PREVIMUC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02847156
• Other study ID #: 69HCL14_0276
• Status: Completed
• Phase: N/A
• First received: July 25, 2016
• Last updated: July 25, 2016
• Start date: January 2015
• Est. completion date: January 2016

Study information

• Verified date: July 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Months

Eligibility

Inclusion Criteria:

• infant <24 months with cystic fibrosis

Exclusion Criteria:

• patient >24 months

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Communicable Diseases
• Cystic Fibrosis
• Fibrosis
• Infection
• Respiratory Viral Infection
• Virus Diseases

Intervention

Other:
• Physical assessment
1 year follow-up in CF infants with clinical, microbiological and therapeutic assessments

Locations

Country	Name	City	State
France	Cystic Fibrosis Pediatric Reference Centrer, Hospices Civils de Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Respiratory Viral Infection		up to 12 months	No
Secondary	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	No
Secondary	Number of antibiotics treatments (oral or IV)		up to 12 months	No
Secondary	Number of bronchodilator administrations		up to 12 months	No
Secondary	Number of corticosteroids administrations		up to 12 months	No
Secondary	Number of hospitalization or hospital admission due to upper or lower RVI		up to 12 months	No
Secondary	Identification of bacterial flora in throat-swabs		up to 12 months	No