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.
Study Type
OBSERVATIONAL
Enrollment
510
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.
Time frame: Up to 5 years
Annual mean change and mean change from baseline in FEV1 (liters) and FEV1 % predicted
Time frame: Baseline to Year 5
Annual number of hospitalizations and the total number of hospitalizations at the end of each year
Time frame: Up to 5 years
Annual number of days hospitalized and the total number of hospitalization days at the end of each year
Time frame: Up to 5 years
Annual mean change and mean change from baseline in body mass index (BMI)
Time frame: 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
Time frame: Up to 5 years
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