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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01375036
First received: June 15, 2011
Last updated: March 18, 2014
Last verified: March 2014

June 15, 2011
March 18, 2014
August 2011
August 2016   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
This proportion will be compared annually over 5 years.
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).
Complete list of historical versions of study NCT01375036 on ClinicalTrials.gov Archive Site
  • Annual mean change and mean change from baseline in FEV1 (liters) and FEV1 % predicted [ Time Frame: Baseline to Year 5 ] [ Designated as safety issue: No ]
  • Annual number of hospitalizations and the total number of hospitalizations at the end of each year [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Annual number of days hospitalized and the total number of hospitalization days at the end of each year [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Annual mean change and mean change from baseline in body mass index (BMI) [ Time Frame: Baseline to Year 5 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
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).
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Registry to Monitor the Susceptibility to Aztreonam of Pseudomonas Aeruginosa Isolates From Cystic Fibrosis Patients
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]

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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Pseudomonas aeruginosa isolates from sputum or throat swab specimens

Non-Probability Sample

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.

Cystic Fibrosis
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
510
February 2017
August 2016   (final data collection date for primary outcome measure)

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.

Both
6 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01375036
GX-US-205-0128
No
Gilead Sciences
Gilead Sciences
Cystic Fibrosis Foundation
Study Director: Mark Bresnik, MD Gilead Sciences
Gilead Sciences
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP