NCT01973192

Viral Pathogenesis of Early Cystic Fibrosis Lung Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 65 (actual)
• Sponsor: Indiana University School of Medicine · Academic / Other
• Sex: All
• Age: 2 Months – 4 Months
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cystic Fibrosis

Timeline

• Start date: 2013-05-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2013-10-31
• Last updated: 2017-04-04

Locations

4 sites across 2 countries: United States, Australia