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]

Gilead Sciences30 sites in 1 country510 target enrollmentAugust 2011

ConditionsCystic Fibrosis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Cystic Fibrosis
Sponsor: Gilead Sciences
Enrollment: 510
Locations: 30
Primary Endpoint: 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)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

December 2016

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Gilead Sciences

Responsible Party

Sponsor

Eligibility Criteria

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.

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.

Outcomes

Primary Outcomes

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)

Time Frame: Up to 5 years

This proportion will be compared annually over 5 years.

Secondary Outcomes

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