Viral Pathogenesis of Early Cystic Fibrosis Lung Disease | NCT01973192

Studies
Viral Pathogenesis of Early Cystic Fibrosis Lung Disease

NCT01973192

Sponsor

Indiana University

Status

Completed

Last Update Posted

Apr 4, 2017Actual

Enrollment

65Actual

Phase

Not provided

Conditions

Cystic Fibrosis

Interventions

Not provided

Countries

United States
Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R01HL116211-01	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Dec 1, 2016Actual

Completion Date

Dec 1, 2016Actual

First Submitted Date

Sep 17, 2013

First Submission Date that Met QC Criteria

Oct 25, 2013

First Posted Date

Oct 31, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2017

Last Update Posted Date

Apr 4, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stephanie D. Davis, MD, Section Director of Pediatric Pulmonology, Allergy and Sleep Medicine, Indiana UniversityPrincipal Investigator

Lead Sponsor

Indiana UniversityOTHER

Collaborators

Name	Class
National Institutes of Health (NIH)	NIH
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

65Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Pulmonary exacerbation rate	To identify the impact of respiratory viruses on the onset, frequency, and duration of respiratory symptoms in CF infants diagnosed through newborn screening.	12 Months
Forced Expiratory Volume

Other Outcomes

Measure	Description	Time Frame
Bronchiectasis	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.	12 Months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Months

Maximum Age

4 Months

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephanie D. Davis, MD	Indiana University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Riley Hospital for Children at Indiana University Health		Indianapolis	Indiana	46202	United States

Condition Browse Module

MeSH Terms

ID	Term
D003550	Cystic Fibrosis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

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Browse Branches

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