Viral Pathogenesis of Early Cystic Fibrosis Lung Disease

NCT01973192 | Completed DMC

• 1 other identifier: 1R01HL116211-01
• Study Type: observational
• Target: 65
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Viral infection

  To determine the effect(s) of viral infections on the evolution of endobronchial bacterial infection and inflammation in CF infants.

  12 months

Secondary Outcomes (2)

• Pulmonary exacerbation rate

  12 Months

• Forced Expiratory Volume

  12 months

Other Outcomes (1)

• Bronchiectasis

  12 Months

Eligibility Criteria

• Age: 2 Months - 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants, less than 4 months of age who have been diagnosed with Cystic Fibrosis

You may qualify if:

• Diagnosis of CF by newborn screening, at least one clinical feature of CF, and documented sweat chloride greater than 60 mEq/L by quantitative pilocarpine iontophoresis or compatible genotype with two identifiable mutant CFTR alleles.
• Less than 4 months of age at Screening Visit
• Ability to comply with study visits and study procedures as judged by site investigator.

You may not qualify if:

• Intercurrent respiratory illness, defined as increase in cough, wheezing, or respiratory rate with onset 14 days before iPFT-bronchoscopy visit.
• Measured hemoglobin oxygen saturation less than 95% during the iPFT-bronchoscopy visit.
• History of adverse reaction to sedation.
• Clinically significant upper airway obstruction as determined by the site investigator.
• Severe gastroesophageal reflux, defined as persistent frequent emesis despite therapy.
• Major organ dysfunction, not including pancreatic dysfunction.
• Physical findings that would compromise the safety of the subject or the quality of the study data as determined by site investigator.

Sponsors & Collaborators

• Indiana University School of Medicine: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (4)

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

The Royal Children's Hospital

Melbourne, Victoria, Australia

Location

Telethon Kids Institute

West Perth, 6872, Australia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood Urea, Bronchopulmonary Lavage samples, Nasal swabs and Oral swabs, Stool samples

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Stephanie D. Davis, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Section Director of Pediatric Pulmonology, Allergy and Sleep Medicine

Study Record Dates

• First Submitted: September 17, 2013
• First Posted: October 31, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 4, 2017

Record last verified: 2017-04

Locations

US (2); AU (2)