AIR-CF5: Registry to Monitor the Susceptibility to Aztreonam of Pseudomonas Aeruginosa Isolates From Cystic Fibrosis Patients

Sponsor

Gilead Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT01375036

Collaborator

Cystic Fibrosis Foundation (Other)

510

Enrollment

Locations

Duration (Months)

16.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis

Study Design

Study Type:

Observational

Actual Enrollment :

510 participants

Time Perspective:

Prospective

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]

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Outcome Measures

Primary Outcome Measures

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) [Up to 5 years]
This proportion will be compared annually over 5 years.

Secondary Outcome Measures

Annual mean change and mean change from baseline in FEV1 (liters) and FEV1 % predicted [Baseline to Year 5]
Annual number of hospitalizations and the total number of hospitalizations at the end of each year [Up to 5 years]
Annual number of days hospitalized and the total number of hospitalization days at the end of each year [Up to 5 years]
Annual mean change and mean change from baseline in body mass index (BMI) [Baseline to Year 5]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Providence Alaska Medical Center	Anchorage	Alaska	United States	99508
2	University of Arizona	Tucson	Arizona	United States	85724
3	Arkansas Children's Hospital Research Institute	Little Rock	Arkansas	United States	72202
4	Children's Hospital of Los Angeles	Los Angeles	California	United States	90027
5	University of Southern California	Los Angeles	California	United States	90033
6	The Children's Hospital	Denver	Colorado	United States	80045
7	National Jewish Health	Denver	Colorado	United States	80206
8	Central Florida Pulmonary Group	Altamonte	Florida	United States	32701
9	Nemours Children's Clinic	Orlando	Florida	United States	32801
10	University of Chicago	Chicago	Illinois	United States	60637
11	Riley Hospital for Children	Indianapolis	Indiana	United States	46202
12	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
13	Massachusetts General Hospital	Boston	Massachusetts	United States	02115
14	Children's Hospitals & Clinics of Minnesota	Minneapolis	Minnesota	United States	55404
15	University of Minnesota	Minneapolis	Minnesota	United States	55455
16	Children's Lung Specialists	Las Vegas	Nevada	United States	89107
17	Albany Medical College	Albany	New York	United States	12208
18	Columbia University Medical Center	New York	New York	United States	10032
19	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599
20	Cincinati Children's Hosptial Medical Center	Cincinnati	Ohio	United States	45229
21	University of Cincinnati Medical Center	Cincinnati	Ohio	United States	45267
22	Nationwide Children's Hospital	Columbus	Ohio	United States	43205
23	The Children's Medical Center of Dayton	Dayton	Ohio	United States	45404
24	Drexel University College of Medicine	Philadelphia	Pennsylvania	United States	19102
25	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
26	St. Christopher's Hospital for Children	Philadelphia	Pennsylvania	United States	19134
27	Medical University of South Carolina	Charleston	South Carolina	United States	29425
28	Baylor College of Medicine	Houston	Texas	United States	77030
29	University of Utah	Salt Lake City	Utah	United States	84132
30	Children's Hospital of Wisconsin	Milwaukee	Wisconsin	United States	53201
31	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226