Registry to Monitor the Susceptibility to Aztreonam of Pseudomonas Aeruginosa Isolates From Cystic Fibrosis Patients (AIR-CF5)
This is a 5-year study that will enroll 500 subjects from the existing Cystic Fibrosis Foundation (CFF) patient registry. Eligible subjects will be patients who receive care at CFF-accredited centers nationwide. Each enrolled subject will provide samples for microbiological evaluation, obtained upon enrollment and then once per year thereafter for 5 years.
|Study Design:||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]|
- Changes in susceptibility among Pseudomonas aeruginosa (PA) isolates to aztreonam [ Time Frame: 5 years ] [ Designated as safety issue: No ]To determine whether there are any changes in susceptibility to aztreonam among Pseudomonas aeruginosa (PA) isolates from subjects with cystic fibrosis (CF) in the United States over the five year period after introduction of Cayston® (aztreonam for inhalation solution).
- Determine whether changes in clinical outcomes are associated with changes in susceptibility of PA isolates to aztreonam. [ Time Frame: 5 years ] [ Designated as safety issue: No ]The secondary objective is to determine whether any changes in susceptibility are associated with changes in clinical outcomes, including changes in lung function, number and duration of hospitalizations, and body mass index (BMI).
Biospecimen Retention: Samples Without DNA
Pseudomonas aeruginosa isolates from sputum or throat swab specimens
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||February 2017|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
This is a prospective, longitudinal study that will enroll a subset of subjects from the existing Cystic Fibrosis Foundation (CFF) patient registry, which includes more than 25,500 patients who receive care at CFF-accredited centers nationwide. This will be a 5-year study embedded within the CFF registry that will include collection of lower respiratory tract samples from 500 subjects each year. These samples for microbiological evaluation will be obtained from each subject upon enrollment and then once per year thereafter.
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|Study Director:||Mark Bresnik, MD||Gilead Sciences|