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Observational Closed to Enrollment

Phase 4 study to monitor the susceptibility of Pseudomonas aeruginosa to aztreonam in people with CF (Gilead GS-US-205-0128)

This observational study investigated the susceptibility of Pseudomonas aeruginosa isolates to aztreonam in people with CF. This study enrolled a subset of subjects from the existing Cystic Fibrosis Foundation (CFF) patient registry, which includes more than 25,500 patients who receive care at CFF-accredited centers nationwide. The study included collection of lower respiratory tract samples from 500 subjects each year and used the CFF national registry as a means of collecting the associated clinical information.

 

Eligibility

  • Age:

    1 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    Less than 90%

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Study Design

  • Study Type: ?more info

    Observational

  • Randomized Study: ?more info

    No

  • Placebo Controlled: ?more info

    No

  • Length of Participation:

    5 years

  • Number of Study Visits:

    5

Additional Information

  • Phase: ?more info

    Phase Four/Post-Approval

  • Study Sponsor: ?more info

    Gilead

  • Study Drugs:

    N/A

Study Sites

  • Closed to Enrollment

    Alaska

    Providence Alaska Medical Center, Anchorage, AK 99508

  • Closed to Enrollment

    Arizona

    Tucson Cystic Fibrosis Center, Tucson, AZ 85724

  • Closed to Enrollment

    Arkansas

    Arkansas Children's Hospital, Little Rock, AR 72202

  • Closed to Enrollment

    California

    Children's Hospital of Los Angeles, Los Angeles, CA 90027

  • Closed to Enrollment

    Florida

    The Nemours Children's Clinic - Orlando, Orlando, FL 32827

  • Closed to Enrollment

    Florida

    Central Florida Pulmonary Group, Orlando, FL 32803

  • Closed to Enrollment

    Illinois

    University of Chicago, Chicago, IL 60637

  • Closed to Enrollment

    Indiana

    Riley Hospital for Children, Indianapolis, IN 46202

  • Closed to Enrollment

    Massachusetts

    Boston Children's Hospital, Boston, MA 02115

  • Closed to Enrollment

    Massachusetts

    Massachusetts General Hospital, Boston, MA 02114

  • Closed to Enrollment

    Minnesota

    The Minnesota Cystic Fibrosis Center, Minneapolis, MN 55454

  • Closed to Enrollment

    Minnesota

    Children’s Hospitals and Clinics of Minnesota, Minneapolis, MN 55404

  • Closed to Enrollment

    New York

    Albany Medical College, Albany, NY 12208

  • Closed to Enrollment

    New York

    Columbia University Cystic Fibrosis Program, New York, NY 10032

  • Closed to Enrollment

    North Carolina

    University of North Carolina at Chapel Hill, Chapel Hill, NC 27599

  • Closed to Enrollment

    Ohio

    Dayton Children's Hospital, Dayton, OH 45404

  • Closed to Enrollment

    Ohio

    Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229

  • Closed to Enrollment

    Ohio

    University of Cincinnati Medical Center, Cincinnati, OH 45267

  • Closed to Enrollment

    Ohio

    Nationwide Children's Hospital, Columbus, OH 43205

  • Closed to Enrollment

    Pennsylvania

    University of Pennsylvania, Philadelphia, PA 19104

  • Closed to Enrollment

    Pennsylvania

    St. Christopher's Hospital for Children, Philadelphia, PA 19134

  • Closed to Enrollment

    South Carolina

    Medical University of South Carolina, Charleston, SC 29425

  • Closed to Enrollment

    Texas

    Baylor College of Medicine, Houston, TX 77030

  • Closed to Enrollment

    Utah

    Primary Children's Cystic Fibrosis Center, Salt Lake City, UT 84113

  • Closed to Enrollment

    Wisconsin

    Children's Hospital of Wisconsin, Milwaukee, WI 53226

  • Closed to Enrollment

    Wisconsin

    Froedtert & Medical College of Wisconsin, Milwaukee, WI 53226

Eligibility

  • Age:

    1 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    Less than 90%

  • Pseudomonas Status:

    Positive Respiratory Cultures Required

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

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