Standardizing Treatments for Pulmonary Exacerbations: A Platform for Evaluating Treatment Decisions to Improve Outcomes (STOP360) Aminoglycoside Study (AG Study)

Status: Recruiting
Location: See all (60) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The purpose of this study is to look at pulmonary exacerbations in people with cystic fibrosis (CF) that need to be treated with antibiotics given through a tube inserted into a vein (intravenous or IV). A pulmonary exacerbation is a worsening of respiratory symptoms in people with CF that needs medical intervention. Both doctors and CF patients are trying to understand the best way to treat pulmonary exacerbations. This study is trying to answer the following questions about treating a pulmonary exacerbation: * Do participants have the same improvement in lung function and symptoms if they are treated with one type of antibiotic (called beta-lactams or β-lactams) versus taking two different types of antibiotics (tobramycin and β-lactams)? * Is taking one type of antibiotic just as good as taking two types?

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Healthy Volunteers: f
View:

• All genders ≥ 6 years of age at Visit 1

• Documentation of a CF diagnosis

• Clinician intent to treat index CF PEx with a planned 14-day course of IV antimicrobials

• At least one documented Pa positive culture within two years prior to Visit 1

Locations
United States
Alabama
The Children's Hospital Alabama, University of Alabama at Birmingham
RECRUITING
Birmingham
Arizona
Tucson Cystic Fibrosis Center
RECRUITING
Tucson
California
University of California San Diego
RECRUITING
La Jolla
Long Beach Memorial Medical Center
RECRUITING
Long Beach
CHOC Children's Hospital
RECRUITING
Orange
University of California at Davis Medical Center
RECRUITING
Sacramento
Washington, D.c.
Children's National Medical Center
NOT_YET_RECRUITING
Washington D.c.
Florida
University of Florida
RECRUITING
Gainesville
Joe DiMaggio Children's Hospital
RECRUITING
Hollywood
Nemours Children's Clinic
RECRUITING
Jacksonville
University of Miami
RECRUITING
Miami
All Children's Hospital
RECRUITING
St. Petersburg
Georgia
Emory University
RECRUITING
Atlanta
Iowa
University of Iowa
RECRUITING
Iowa City
Idaho
Saint Luke's Cystic Fibrosis Center of Idaho
RECRUITING
Boise
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
RECRUITING
Chicago
Northwestern University
RECRUITING
Chicago
OSF Saint Francis Medical Center
RECRUITING
Peoria
Indiana
Indiana University Medical Center
RECRUITING
Indianapolis
Riley Hospital for Children
RECRUITING
Indianapolis
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Kentucky
University of Louisville
RECRUITING
Louisville
Massachusetts
Boston Children's Hospital, Brigham & Women's Hospital
RECRUITING
Boston
University of Massachusetts Memorial Health Care
RECRUITING
Worcester
Maryland
John Hopkins Hospital
RECRUITING
Baltimore
Maine
Maine Medical Center
RECRUITING
Portland
Michigan
University of Michigan, Michigan Medicine
RECRUITING
Ann Arbor
Helen DeVos Children's Hospital
RECRUITING
Grand Rapids
Missouri
SSM Health Cardinal Glennon Children's Hospital
RECRUITING
St Louis
Washington University School of Medicine
RECRUITING
St Louis
Montana
Billings Clinic
RECRUITING
Billings
New Hampshire
Dartmouth Hitchcock Medical Center
RECRUITING
Lebanon
New Jersey
Morristown Medical Center
RECRUITING
Morristown
Rutgers - Robert Wood Johnson Medical School
RECRUITING
New Brunswick
New York
Children's Hospital of New York
RECRUITING
New York
Lenox Hill Hospital Cystic Fibrosis Center
RECRUITING
New York
New York Medical College at Westchester Medical Center
RECRUITING
Valhalla
Ohio
Children's Hospital Medical Center of Akron
RECRUITING
Akron
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
University of Cincinnati Medical Center
RECRUITING
Cincinnati
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Nationwide Children's Hospital
RECRUITING
Columbus
Dayton Children's Hospital
RECRUITING
Dayton
Toledo Children's Hospital
RECRUITING
Toledo
Oklahoma
Oklahoma Cystic Fibrosis Center
RECRUITING
Oklahoma City
Oregon
Oregon Health Sciences University
RECRUITING
Portland
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Children's Hospital of Pittsburgh of UPMC
RECRUITING
Pittsburgh
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Tennessee
Vanderbilt Children's Hospital
RECRUITING
Nashville
Texas
University of Texas Southwestern
RECRUITING
Dallas
University of Texas Southwestern / Children's Health
RECRUITING
Dallas
Cook Children's Medical Center
RECRUITING
Fort Worth
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Washington
Seattle Children's Hospital
RECRUITING
Seattle
University of Washington Medical Center
RECRUITING
Seattle
Providence Medical Group, Cystic Fibrosis Clinic
RECRUITING
Spokane
Wisconsin
University of Wisconsin
RECRUITING
Madison
West Virginia
West Virginia University - Morgantown
RECRUITING
Morgantown
Other Locations
Canada
University of Calgary Adult Cystic Fibrosis Clinic (Calgary, AB)
RECRUITING
Calgary
Contact Information
Primary
Rachael Buckingham, BS
Rachael.buckingham@seattlechildrens.org
206-884-7517
Backup
Barbra Fogarty
Barbra.fogarty@seattlechildrens.org
206-884-7592
Time Frame
Start Date: 2023-04-23
Estimated Completion Date: 2026-11-15
Participants
Target number of participants: 730
Treatments
Other: β-lactam Only (Non-AG)
Participants randomized to this arm will be prescribed a standard of care intravenous (IV) β-lactam as selected by their treating physician. Treatment must not include an IV aminoglycoside.
Other: β-lactam and Aminoglycoside (AG)
Participants randomized to this arm will be prescribed a standard of care intravenous (IV) β-lactam and aminoglycoside selected by their treating physician.
Related Therapeutic Areas
Sponsors
Collaborators: Medical University of South Carolina, University of Washington, Cystic Fibrosis Foundation
Leads: Chris Goss

This content was sourced from clinicaltrials.gov