Registry to Monitor the Susceptibility to Aztreonam of Pseudomonas Aeruginosa Isolates From Cystic Fibrosis Patients
AIR-CF5
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]
1 other identifier
observational
510
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2011
Longer than P75 for all trials
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2011
CompletedFirst Posted
Study publicly available on registry
June 17, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJanuary 11, 2017
January 1, 2017
5.3 years
June 15, 2011
January 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (5)
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
A representative cross-section of individuals with mild (FEV1 75% to ≤ 90% predicted), moderate (FEV1 40% to 74% predicted), or severe (FEV1 \<40% predicted) lung disease and a history of ≥ 2 lower respiratory tract cultures positive for PA (at any time) will be enrolled. This will include approximately 100 individuals with pre-study exposure to Cayston (defined as having received at least one prior 28-day course of Cayston at any time before enrolling into the study). Enrollment will be monitored and potentially modified to ensure that adequate numbers of participants in each disease severity category are included. At the Investigator's discretion, participants enrolled in this study can be allowed to participate in clinical trials with other investigational therapies as appropriate.
You may qualify if:
- 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.
You may not qualify if:
- Any serious active medical or psychiatric illness that, in the opinion of the Investigator, would interfere with subject assessment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
- Cystic Fibrosis Foundationcollaborator
Study Sites (31)
Providence Alaska Medical Center
Anchorage, Alaska, 99508, United States
University of Arizona
Tucson, Arizona, 85724, United States
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72202, United States
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
University of Southern California
Los Angeles, California, 90033, United States
The Children's Hospital
Denver, Colorado, 80045, United States
National Jewish Health
Denver, Colorado, 80206, United States
Central Florida Pulmonary Group
Altamonte, Florida, 32701, United States
Nemours Children's Clinic
Orlando, Florida, 32801, United States
University of Chicago
Chicago, Illinois, 60637, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Massachusetts General Hospital
Boston, Massachusetts, 02115, United States
Children's Hospitals & Clinics of Minnesota
Minneapolis, Minnesota, 55404, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Children's Lung Specialists
Las Vegas, Nevada, 89107, United States
Albany Medical College
Albany, New York, 12208, United States
Columbia University Medical Center
New York, New York, 10032, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Cincinati Children's Hosptial Medical Center
Cincinnati, Ohio, 45229, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
The Children's Medical Center of Dayton
Dayton, Ohio, 45404, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53201, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
Keating CL, Zuckerman JB, Singh PK, McKevitt M, Gurtovaya O, Bresnik M, Marshall BC, Saiman L. Pseudomonas aeruginosa Susceptibility Patterns and Associated Clinical Outcomes in People with Cystic Fibrosis following Approval of Aztreonam Lysine for Inhalation. Antimicrob Agents Chemother. 2021 Feb 17;65(3):e02327-20. doi: 10.1128/AAC.02327-20. Print 2021 Feb 17.
PMID: 33318007DERIVED
Biospecimen
Pseudomonas aeruginosa isolates from sputum or throat swab specimens
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2011
First Posted
June 17, 2011
Study Start
August 1, 2011
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
January 11, 2017
Record last verified: 2017-01