Impact of Respiratory Viral Infections in Infants With Cystic Fibrosis. (PREVIMUC)
|ClinicalTrials.gov Identifier: NCT02847156|
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : July 28, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis Respiratory Viral Infection||Other: Physical assessment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical and Microbiological Impact of Respiratory Viral Infections in the Short and Medium Term in Infants (<24 Months) With Cystic Fibrosis.|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
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
- Number of Respiratory Viral Infection [ Time Frame: up to 12 months ]
- Identification of respiratory viruses in throat-swabs [ Time Frame: up to 12 months ]A panel of 10 viruses will be tested using polymerase chain reaction (PCR) and RT-PCR technology.
- Number of antibiotics treatments (oral or IV) [ Time Frame: up to 12 months ]
- Number of bronchodilator administrations [ Time Frame: up to 12 months ]
- Number of corticosteroids administrations [ Time Frame: up to 12 months ]
- Number of hospitalization or hospital admission due to upper or lower RVI [ Time Frame: up to 12 months ]
- Identification of bacterial flora in throat-swabs [ Time Frame: up to 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02847156
|Cystic Fibrosis Pediatric Reference Centrer, Hospices Civils de Lyon|
|Bron, France, 69677|
|Principal Investigator:||Stéphanie VRIELYNCK, MD||Cystic Fibrosis Pediatric Reference Centrer, Hospices Civils de Lyon, 69677 Bron Cedex, France|