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OpenTrials
Completed

NCT Number: NCT02847156

Impact of Respiratory Viral Infections in Infants 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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Infections Lung Diseases Pancreatic Diseases Respiratory Tract Diseases Respiratory Viral Infection Virus Diseases

Age range

Up to 24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cystic Fibrosis Pediatric Reference Centrer, Hospices Civils de Lyon

Bron, 69677, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • infant <24 months with cystic fibrosis

Exclusion criteria

  • patient >24 months

Treatment and study plan

Physical assessment

Other

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

Primary outcomes

  1. Number of Respiratory Viral Infection

    Time frame: up to 12 months

Secondary outcomes

  1. 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.

  2. Number of antibiotics treatments (oral or IV)

    Time frame: up to 12 months

  3. Number of bronchodilator administrations

    Time frame: up to 12 months

  4. Number of corticosteroids administrations

    Time frame: up to 12 months

  5. Number of hospitalization or hospital admission due to upper or lower RVI

    Time frame: up to 12 months

  6. Identification of bacterial flora in throat-swabs

    Time frame: up to 12 months

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: PREVIMUC

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 28, 2016
Registry last updated
Jul 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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