Registry to Monitor the Susceptibility to Aztreonam of Pseudomonas Aeruginosa Isolates From Cystic Fibrosis Patients
NCT ID: NCT01375036
Last Updated: 2017-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
510 participants
OBSERVATIONAL
2011-08-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* ≥ 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
• Any serious active medical or psychiatric illness that, in the opinion of the Investigator, would interfere with subject assessment.
6 Years
ALL
No
Sponsors
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Cystic Fibrosis Foundation
OTHER
Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Providence Alaska Medical Center
Anchorage, Alaska, United States
University of Arizona
Tucson, Arizona, United States
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States
Children's Hospital of Los Angeles
Los Angeles, California, United States
University of Southern California
Los Angeles, California, United States
The Children's Hospital
Denver, Colorado, United States
National Jewish Health
Denver, Colorado, United States
Central Florida Pulmonary Group
Altamonte, Florida, United States
Nemours Children's Clinic
Orlando, Florida, United States
University of Chicago
Chicago, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Children's Hospitals & Clinics of Minnesota
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Children's Lung Specialists
Las Vegas, Nevada, United States
Albany Medical College
Albany, New York, United States
Columbia University Medical Center
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Cincinati Children's Hosptial Medical Center
Cincinnati, Ohio, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
The Children's Medical Center of Dayton
Dayton, Ohio, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Baylor College of Medicine
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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GX-US-205-0128
Identifier Type: -
Identifier Source: org_study_id
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