We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01375036
Recruitment Status : Completed
First Posted : June 17, 2011
Last Update Posted : January 11, 2017
Cystic Fibrosis Foundation Therapeutics
Information provided by (Responsible Party):
Gilead Sciences

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.

Condition or disease
Cystic Fibrosis

Study Type : Observational
Actual Enrollment : 510 participants
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]
Study Start Date : August 2011
Primary Completion Date : December 2016
Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Annual mean change and mean change from baseline in FEV1 (liters) and FEV1 % predicted [ Time Frame: Baseline to Year 5 ]
  2. Annual number of hospitalizations and the total number of hospitalizations at the end of each year [ Time Frame: Up to 5 years ]
  3. Annual number of days hospitalized and the total number of hospitalization days at the end of each year [ Time Frame: Up to 5 years ]
  4. Annual mean change and mean change from baseline in body mass index (BMI) [ Time Frame: Baseline to Year 5 ]
  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 ]

Biospecimen Retention:   Samples Without DNA
Pseudomonas aeruginosa isolates from sputum or throat swab specimens

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01375036

  Show 31 Study Locations
Sponsors and Collaborators
Gilead Sciences
Cystic Fibrosis Foundation Therapeutics
Study Director: Gilead Study Director Gilead Sciences

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01375036     History of Changes
Other Study ID Numbers: GX-US-205-0128
First Posted: June 17, 2011    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017

Keywords provided by Gilead Sciences:
Cystic fibrosis
Pseudomonas aeruginosa

Additional relevant MeSH terms:
Cystic Fibrosis
Disease Susceptibility
Pseudomonas Infections
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Disease Attributes
Gram-Negative Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents