Viral Pathogenesis of Early Cystic Fibrosis Lung Disease (Early CF)
The purpose of this study is to test the hypothesis that early viral infections alter the bacterial flora and inflammatory profile in the airway and accelerate progression of pulmonary disease in infants with cystic fibrosis.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Viral Pathogenesis of Early Cystic Fibrosis Lung Disease|
- Viral infection [ Time Frame: 12 months ] [ Designated as safety issue: No ]To determine the effect(s) of viral infections on the evolution of endobronchial bacterial infection and inflammation in CF infants.
- Pulmonary exacerbation rate [ Time Frame: 12 Months ] [ Designated as safety issue: No ]To identify the impact of respiratory viruses on the onset, frequency, and duration of respiratory symptoms in CF infants diagnosed through newborn screening.
- Forced Expiratory Volume [ Time Frame: 12 months ] [ Designated as safety issue: No ]To assess development of early lung disease as defined through physiological measures of forced expiratory flows, lung volumes, and ventilation inhomogeneity in CF infants.
- Bronchiectasis [ Time Frame: 12 Months ] [ Designated as safety issue: No ]To evaluate the association of early viruses on the development of early lung disease in CF infants as defined through comprehensive structural and airway modeling techniques.
Biospecimen Retention: Samples With DNA
Blood Urea, Bronchopulmonary Lavage samples, Nasal swabs and Oral swabs
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
The proposed study is a unique international collaboration between three large CF research centers. This proposal will determine the impact of early respiratory viral infections on bacterial flora and inflammatory profiles in the CF airway as well as the impact of these pathogens on clinical, physiologic and structural markers of disease.The proposed study is designed to follow infants diagnosed with CF through newborn screening to determine the effect of viral infections on the lower airway microbiome, clinical symptoms, pulmonary function and structural changes during the first year of life. The proposed study will measure lower airway inflammation and infection using BAL, oral swabs, and nasal swabs; outcomes will be assessed through infant lung function testing, computerized tomography scans of the chest, and pulmonary exacerbation rate.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01973192
|Contact: Mary Heskett, RN, CCRPemail@example.com|
|United States, Indiana|
|Riley Hospital for Children at Indiana University Health||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Mary Heskett, RN, BSN, CCRP firstname.lastname@example.org|
|Principal Investigator: Stephanie D Davis, MD|
|United States, Missouri|
|St. Louis Children's Hospital||Recruiting|
|St. Louis, Missouri, United States|
|Contact: Jane Quante 314-454-2353 email@example.com|
|Principal Investigator: Thomas Ferkol, MD|
|The Royal Children's Hospital||Recruiting|
|Melbourne, Victoria, Australia|
|Contact: Billy Skoric +011-61-3-9345-5843 firstname.lastname@example.org|
|Principal Investigator: Sarath Ranganathan, MD|
|Principal Investigator:||Stephanie D. Davis, MD||Indiana University School of Medicine|