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Anti-Infective Closed to Enrollment

STOP 2: Treatment of pulmonary exacerbations in people with CF (STOP2-IP-15)

This study is taking place at multiple care centers across the U.S. It will look at the safety and effectiveness of different lengths of IV treatment for pulmonary exacerbations in people with CF.

 Pulmonary exacerbations are treated with varying antibiotics for varying time periods based on individual needs determined by patients, their families and care providers. This study will look at the safety and effectiveness of three different lengths of IV antibiotic treatment for pulmonary exacerbations. Participants who respond early to IV treatment will receive antibiotics for 10 or 14 days. Those who do not respond early will receive antibiotics for 14 or 21 days. Researchers will study the effectiveness of different IV treatment lengths by measuring changes in lung function.This study is for people with CF who experience a pulmonary exacerbation and are planning to receive IV antibiotic treatment. This study may require lung function tests and/or other measurements.

Eligibility

  • Age:

    18 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    No FEV1 Limit

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

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    Yes

  • Placebo Controlled: ?more info

    No

  • Length of Participation:

    35 days

  • Number of Study Visits:

    3

Additional Information

  • Phase: ?more info

    Not Applicable

  • Study Sponsor: ?more info

    Flume, Patrick

  • Study Drugs:

    N/A

Study Sites

  • Closed to Enrollment

    Alabama

    University of Alabama at Birmingham, Birmingham, AL 35294

  • 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

    California

    University of California at Davis Medical Center, Sacramento, CA 95817

  • Closed to Enrollment

    California

    University of California San Diego, La Jolla, CA 92093

  • Closed to Enrollment

    California

    Stanford University Medical Center, Palo Alto, CA 94304

  • Closed to Enrollment

    Colorado

    National Jewish Health, Denver, CO 80206

  • Closed to Enrollment

    Connecticut

    Yale University School of Medicine, New Haven, CT 06520

  • Closed to Enrollment

    Connecticut

    The Marie and Raymond Beauregard Adult CF Center at Hartford Hospital, Hartford, CT 06102

  • Closed to Enrollment

    Florida

    University of Florida, Gainesville, FL 32610

  • Closed to Enrollment

    Florida

    University of Miami, Miami, FL 33136

  • Closed to Enrollment

    Florida

    Joe DiMaggio Children's Hospital, Hollywood, FL 33021

  • Closed to Enrollment

    Georgia

    Augusta University, Augusta, GA 30912

  • Closed to Enrollment

    Georgia

    Emory University, Atlanta, GA 30327

  • Closed to Enrollment

    Idaho

    Saint Luke's Cystic Fibrosis Center of Idaho, Boise, ID 83702

  • Closed to Enrollment

    Illinois

    OSF Saint Francis Medical Center, Peoria, IL 61637

  • Closed to Enrollment

    Indiana

    Indiana University Medical Center, Indianapolis, IN 46202

  • Closed to Enrollment

    Kansas

    University of Kansas Medical Center, Kansas City, KS 66160

  • Closed to Enrollment

    Maryland

    Johns Hopkins University, Baltimore, MD 21205

  • Closed to Enrollment

    Massachusetts

    University of Massachusetts Memorial Health Care, Worcester, MA 01605

  • Closed to Enrollment

    Massachusetts

    Boston Children's Hospital, Brigham & Women's Hospital, Boston, MA 02115

  • Closed to Enrollment

    Michigan

    University of Michigan Health System, Ann Arbor, MI 48109

  • Closed to Enrollment

    Michigan

    Wayne State University Harper University Hospital, Detroit, MI 48201

  • Closed to Enrollment

    Missouri

    Washington University School of Medicine, St. Louis, MO 63110

  • Closed to Enrollment

    Missouri

    SSM Health Saint Louis University Hospital, St. Louis, MO 63110

  • Closed to Enrollment

    Montana

    Billings Clinic , Billings, MT 59101

  • Closed to Enrollment

    New Hampshire

    Dartmouth Hitchcock Medical Center, Lebanon, NH 03756

  • Closed to Enrollment

    New Jersey

    Morristown Medical Center , Morristown, NJ 07960

  • Closed to Enrollment

    New Jersey

    Monmouth Medical Center, Eatontown, NJ 07724

  • Closed to Enrollment

    New Jersey

    Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ 08903

  • Closed to Enrollment

    New York

    Long Island Jewish Medical Center, New Hyde Park, NY 11042

  • Closed to Enrollment

    New York

    Columbia University Cystic Fibrosis Program, New York, NY 10032

  • Closed to Enrollment

    New York

    Beth Israel Medical Center, New York, NY 10003

  • Closed to Enrollment

    New York

    SUNY Upstate Medical University, Syracuse, NY 13210

  • Closed to Enrollment

    New York

    New York Medical College at Westchester Medical Center, Valhalla, NY 10595

  • Closed to Enrollment

    New York

    The Cystic Fibrosis Center of Western New York, Buffalo, NY 14203

  • Closed to Enrollment

    New York

    University of Rochester Medical Center Strong Memorial, Rochester, NY 14609

  • Closed to Enrollment

    North Carolina

    University of North Carolina at Chapel Hill, Chapel Hill, NC 27517

  • Closed to Enrollment

    North Carolina

    Wake Forest University Baptist Medical Center, Winston-Salem, NC 27157

  • Closed to Enrollment

    Ohio

    Nationwide Children's Hospital, Columbus, OH 43205

  • Closed to Enrollment

    Ohio

    Wright State University, Dayton, OH 45404

  • Closed to Enrollment

    Ohio

    Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland, OH 44146

  • Closed to Enrollment

    Ohio

    Children's Hospital Medical Center of Akron, Akron, OH 44308

  • Closed to Enrollment

    Pennsylvania

    Hershey Medical Center Pennsylvania State University, Hershey, PA 17033

  • Closed to Enrollment

    Pennsylvania

    University of Pennsylvania, Philadelphia, PA 19104

  • Closed to Enrollment

    Pennsylvania

    University of Pittsburgh Medical Center, Pittsburgh, PA 15224

  • 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

    Texas

    University of Texas Southwestern, Dallas, TX 75390

  • Closed to Enrollment

    Texas

    University of Texas Health Center at Tyler, Tyler, TX 75708

  • Closed to Enrollment

    Vermont

    University of Vermont Medical Center, Burlington, VT 05401

  • Closed to Enrollment

    Virginia

    Virginia Commonwealth University, Richmond, VA 23298

  • Closed to Enrollment

    Virginia

    University of Virginia, Charlottesville, VA 22908

  • Closed to Enrollment

    Washington

    University of Washington Medical Center, Seattle, WA 98195

  • Closed to Enrollment

    West Virginia

    West Virginia University - Morgantown, Morgantown, WV 26507

  • Closed to Enrollment

    Wisconsin

    University of Wisconsin, Madison, WI 53792

  • Closed to Enrollment

    Wisconsin

    Froedtert & Medical College of Wisconsin, Milwaukee, WI 53226

Eligibility

  • Age:

    18 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    No FEV1 Limit

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

Related Topics

  • Questions to Ask When Considering a Specific Trial

    Clinical trials that test potential drugs and therapies in people with cystic fibrosis are a major part of CF research. They take place at Cystic Fibrosis Foundation-accredited care centers all over the United States and enroll people with CF of all ages.

  • Patient Safety Is a Priority

    Nothing is more important than patient safety in developing new treatments for cystic fibrosis. The U.S. government requires that all clinical trials are supervised for safety, and the Cystic Fibrosis Foundation adds additional measures to protect study volunteers.

  • Trikafta™

    The following is a collection of information and news about Trikafta™, the triple-combination modulator therapy that was approved by the U.S. Food and Drug Administration on Oct. 21, 2019.

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