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

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ClinicalTrials.gov Identifier: NCT02847156
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Respiratory Viral Infection Other: Physical assessment Not Applicable

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Number of Respiratory Viral Infection [ Time Frame: up to 12 months ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- infant <24 months with cystic fibrosis

Exclusion Criteria:

- patient >24 months


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02847156


Locations
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France
Cystic Fibrosis Pediatric Reference Centrer, Hospices Civils de Lyon
Bron, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Stéphanie VRIELYNCK, MD Cystic Fibrosis Pediatric Reference Centrer, Hospices Civils de Lyon, 69677 Bron Cedex, France

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02847156     History of Changes
Other Study ID Numbers: 69HCL14_0276
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016
Keywords provided by Hospices Civils de Lyon:
cystic fibrosis
viruses
respiratory viral infection
children
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Infection
Communicable Diseases
Virus Diseases
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases