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

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ClinicalTrials.gov Identifier: NCT01375036
Recruitment Status : Completed
First Posted : June 17, 2011
Last Update Posted : January 11, 2017
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date June 15, 2011
First Posted Date June 17, 2011
Last Update Posted Date January 11, 2017
Study Start Date August 2011
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 18, 2014)
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.
Original Primary Outcome Measures
 (submitted: June 16, 2011)
Changes in susceptibility among Pseudomonas aeruginosa (PA) isolates to aztreonam [ Time Frame: 5 years ]
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).
Change History
Current Secondary Outcome Measures
 (submitted: March 18, 2014)
  • 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 ]
Original Secondary Outcome Measures
 (submitted: June 16, 2011)
Determine whether changes in clinical outcomes are associated with changes in susceptibility of PA isolates to aztreonam. [ Time Frame: 5 years ]
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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Registry to Monitor the Susceptibility to Aztreonam of Pseudomonas Aeruginosa Isolates From Cystic Fibrosis Patients
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]
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.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Pseudomonas aeruginosa isolates from sputum or throat swab specimens
Sampling Method Non-Probability Sample
Study Population 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.
Condition Cystic Fibrosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 18, 2014)
510
Original Estimated Enrollment
 (submitted: June 16, 2011)
500
Actual Study Completion Date December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.

Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01375036
Other Study ID Numbers GX-US-205-0128
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Gilead Sciences
Study Sponsor Gilead Sciences
Collaborators Cystic Fibrosis Foundation
Investigators
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date January 2017