Cystic FibrosisAIR-CF5NCT01375036
Registry to Monitor the Susceptibility to Aztreonam of Pseudomonas Aeruginosa Isolates From Cystic Fibrosis Patients
An observational study of Cystic Fibrosis, run by Gilead Sciences at 31 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 510 participants
- Where
- 31 sitesUnited States
- Study dates
- Aug 2011to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Albany Medical College
Albany, New York, 12208
Central Florida Pulmonary Group
Altamonte, Florida, 32701
Providence Alaska Medical Center
Anchorage, Alaska, 99508
Massachusetts General Hospital
Boston, Massachusetts, 02114
Massachusetts General Hospital
Boston, Massachusetts, 02115
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Chicago
Chicago, Illinois, 60637
Cincinati Children's Hosptial Medical Center
Cincinnati, Ohio, 45229
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
Nationwide Children's Hospital
Columbus, Ohio, 43205
The Children's Medical Center of Dayton
Dayton, Ohio, 45404
The Children's Hospital
Denver, Colorado, 80045
National Jewish Health
Denver, Colorado, 80206
Baylor College of Medicine
Houston, Texas, 77030
Riley Hospital for Children
Indianapolis, Indiana, 46202
Children's Lung Specialists
Las Vegas, Nevada, 89107
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72202
Children's Hospital of Los Angeles
Los Angeles, California, 90027
University of Southern California
Los Angeles, California, 90033
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53201
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Children's Hospitals & Clinics of Minnesota
Minneapolis, Minnesota, 55404
University of Minnesota
Minneapolis, Minnesota, 55455
Columbia University Medical Center
New York, New York, 10032
Nemours Children's Clinic
Orlando, Florida, 32801
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
University of Utah
Salt Lake City, Utah, 84132
University of Arizona
Tucson, Arizona, 85724
About this study
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]
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.
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, PA, Pseudomonas aeruginosa, CF, aztreonam
- Medical subject headings
- Cystic Fibrosis, Pseudomonas Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 years
Secondary outcomes (5)
Annual mean change and mean change from baseline in FEV1 (liters) and FEV1 % predicted
Measured: Baseline to Year 5
Annual number of hospitalizations and the total number of hospitalizations at the end of each year
Measured: Up to 5 years
Annual number of days hospitalized and the total number of hospitalization days at the end of each year
Measured: Up to 5 years
Annual mean change and mean change from baseline in body mass index (BMI)
Measured: 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
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 510 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01375036
- Sponsor's protocol ID
- GX-US-205-0128
- Acronym
- AIR-CF5
- Status last verified
- Jan 2017
- First submitted
- 15 Jun 2011
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Keating CL, Zuckerman JB, Singh PK, McKevitt M, Gurtovaya O, Bresnik M, Marshall BC, Saiman L. Pseudomonas aeruginosa Susceptibility Patterns and Associated Clinical Outcomes in People with Cystic Fibrosis following Approval of Aztreonam Lysine for Inhalation. Antimicrob Agents Chemother. 2021 Feb 17;65(3):e02327-20. doi: 10.1128/AAC.02327-20. Print 2021 Feb 17.
PubMed 33318007
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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]
- ClinicalTrials.gov ID
- NCT01375036
- Acronym / sponsor ID
- AIR-CF5 / GX-US-205-0128
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, PA, Pseudomonas aeruginosa, CF, aztreonam
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 510 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- Aug 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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 (10 listed)
- 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
- FEV1 ≥ 25% predicted and ≤ 90% predicted.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Derived from this study: PubMed 33318007Keating CL, Zuckerman JB, Singh PK, McKevitt M, Gurtovaya O, Bresnik M, Marshall BC, Saiman L. Pseudomonas aeruginosa Susceptibility Patterns and Associated Clinical Outcomes in People with Cystic Fibrosis following Approval of Aztreonam Lysine for Inhalation. Antimicrob Agents Chemother. 2021 Feb 17;65(3):e02327-20. doi: 10.1128/AAC.02327-20. Print 2021 Feb 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Gilead Sciences at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01375036, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.