Registry to Monitor the Susceptibility to Aztreonam of Pseudomonas Aeruginosa Isolates From Cystic Fibrosis Patients

Cystic Fibrosis Clinical Trial

— AIR-CF5  

Official title:

A Prospective, 5-year Registry Study to Monitor the Susceptibility to Aztreonam of Pseudomonas Aeruginosa (PA) Isolates From Patients With Cystic Fibrosis in the United States [AIR-CF5]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01375036
• Other study ID #: GX-US-205-0128
• Status: Completed
• Phase: N/A
• First received: June 15, 2011
• Last updated: January 9, 2017
• Start date: August 2011
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

This is a prospective, longitudinal, 5-year study that will enroll participants from the existing Cystic Fibrosis Foundation (CFF) patient registry. Each enrolled participant will provide samples for microbiological evaluation, obtained upon enrollment and then once per year thereafter for 5 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 510
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

Key Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.

• Current participant or willingness to participate in the CFF patient registry database

• = 6 years of age

• Subject has CF as diagnosed by one of the following

• Documented sweat chloride = 60 mEq/L by quantitative pilocarpine iontophoresis test, or

• Two well-characterized genetic mutations in the CFTR gene, or

• Abnormal nasal potential difference (NPD) AND accompanying clinical characteristics consistent with CF. For subjects who lack documentation of either a positive sweat chloride test or an abnormal NPD, and who have only one well-characterized genetic mutation of the CFTR gene, the diagnosis of CF is determined by the Investigator.

• FEV1 = 25% predicted and = 90% predicted.

• = 2 lower respiratory tract cultures positive for PA with results documented in the subject's medical history.

• Subject must be able to provide written informed consent/assent prior to any study related procedure; parent/guardian must be able to give written informed consent as necessary prior to any study related procedure.

Key Exclusion Criteria:

Subjects who meet the following exclusion criterion are not to be enrolled in this study.

• Any serious active medical or psychiatric illness that, in the opinion of the Investigator, would interfere with subject assessment.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cystic Fibrosis
• Disease Susceptibility
• Fibrosis
• Pseudomonas Infections

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York
United States	Central Florida Pulmonary Group	Altamonte	Florida
United States	Providence Alaska Medical Center	Anchorage	Alaska
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Chicago	Chicago	Illinois
United States	Cincinati Children's Hosptial Medical Center	Cincinnati	Ohio
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	The Children's Medical Center of Dayton	Dayton	Ohio
United States	National Jewish Health	Denver	Colorado
United States	The Children's Hospital	Denver	Colorado
United States	Baylor College of Medicine	Houston	Texas
United States	Riley Hospital for Children	Indianapolis	Indiana
United States	Children's Lung Specialists	Las Vegas	Nevada
United States	Arkansas Children's Hospital Research Institute	Little Rock	Arkansas
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Children's Hospitals & Clinics of Minnesota	Minneapolis	Minnesota
United States	University of Minnesota	Minneapolis	Minnesota
United States	Columbia University Medical Center	New York	New York
United States	Nemours Children's Clinic	Orlando	Florida
United States	Drexel University College of Medicine	Philadelphia	Pennsylvania
United States	St. Christopher's Hospital for Children	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Utah	Salt Lake City	Utah
United States	University of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Gilead Sciences	Cystic Fibrosis Foundation Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants whose least susceptible Pseudomonas aeruginosa (PA) isolate has a = 4-fold increase in aztreonam minimum inhibitory concentration over 1 year and is above the parenteral breakpoint (> 8 µg/mL)	This proportion will be compared annually over 5 years.	Up to 5 years	No
Secondary	Annual mean change and mean change from baseline in FEV1 (liters) and FEV1 % predicted		Baseline to Year 5	No
Secondary	Annual number of hospitalizations and the total number of hospitalizations at the end of each year		Up to 5 years	No
Secondary	Annual number of days hospitalized and the total number of hospitalization days at the end of each year		Up to 5 years	No
Secondary	Annual mean change and mean change from baseline in body mass index (BMI)		Baseline to Year 5	No
Secondary	Annual number of Cayston treatment courses per participant and the total number of Cayston treatment courses at the end of each year in participants that used Cayston		Up to 5 years	No