RECRUITING

Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study

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Conditions

Cystic FibrosisCystic Fibrosis Pulmonary ExacerbationCFaminoglycosidebeta-lactamβ-lactamSTOPSTOP360

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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?

Official Title

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

Quick Facts

Study Start:2023-04-23
Study Completion:2026-11-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05548283

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * All genders ≥ 6 years of age at Visit 1
  2. * Documentation of a CF diagnosis
  3. * Clinician intent to treat index CF PEx with a planned 14-day course of IV antimicrobials
  4. * At least one documented Pa positive culture within two years prior to Visit 1
  1. * Participant is not pregnant
  2. * No known renal impairment or history of solid organ transplantation
  3. * No IV antimicrobial treatment, ICU admission, pneumothorax, or hemoptysis within 6 weeks prior to Visit 1
  4. * No use of investigational therapies, new CF transmembrane conductance regulator (CFTR) modulators, or treatment for Nontuberculous mycobacteria (NTM) within 4 weeks prior to Visit 1
  5. * No history of hypersensitivity, vestibular, or auditory toxicity with aminoglycosides
  6. * No more than one day of IV aminoglycosides administered for the current PEx treatment prior to Visit 1

Contacts and Locations

Study Contact

Rachael Buckingham, BS
CONTACT
206-884-7517
Rachael.buckingham@seattlechildrens.org
Barbra Fogarty
CONTACT
206-884-7592
Barbra.fogarty@seattlechildrens.org

Principal Investigator

Patrick Flume, MD
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina

Study Locations (Sites)

The Children's Hospital Alabama, University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
Tucson Cystic Fibrosis Center
Tucson, Arizona, 85724
United States
University of California San Diego
La Jolla, California, 92093
United States
Long Beach Memorial Medical Center
Long Beach, California, 90806
United States
CHOC Children's Hospital
Orange, California, 92868
United States
University of California at Davis Medical Center
Sacramento, California, 95817
United States
Children's National Medical Center
Washington, District of Columbia, 20010
United States
University of Florida
Gainesville, Florida, 32610
United States
Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
United States
Nemours Children's Clinic
Jacksonville, Florida, 32207
United States
University of Miami
Miami, Florida, 33136
United States
All Children's Hospital
Saint Petersburg, Florida, 33701
United States
Emory University
Atlanta, Georgia, 30327
United States
Saint Luke's Cystic Fibrosis Center of Idaho
Boise, Idaho, 83702
United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States
Northwestern University
Chicago, Illinois, 60611
United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
United States
Indiana University Medical Center
Indianapolis, Indiana, 46202
United States
Riley Hospital for Children
Indianapolis, Indiana, 46202
United States
University of Iowa
Iowa City, Iowa, 52242
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
University of Louisville
Louisville, Kentucky, 40202
United States
Maine Medical Center
Portland, Maine, 04102
United States
John Hopkins Hospital
Baltimore, Maryland, 21205
United States
Boston Children's Hospital, Brigham & Women's Hospital
Boston, Massachusetts, 02115
United States
University of Massachusetts Memorial Health Care
Worcester, Massachusetts, 01655
United States
University of Michigan, Michigan Medicine
Ann Arbor, Michigan, 48109
United States
Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49546
United States
SSM Health Cardinal Glennon Children's Hospital
Saint Louis, Missouri, 63104
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Billings Clinic
Billings, Montana, 59101
United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
Morristown Medical Center
Morristown, New Jersey, 07960
United States
Rutgers - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
United States
Lenox Hill Hospital Cystic Fibrosis Center
New York, New York, 10003
United States
Children's Hospital of New York
New York, New York, 10032
United States
New York Medical College at Westchester Medical Center
Valhalla, New York, 10595
United States
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
United States
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44146
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
Dayton Children's Hospital
Dayton, Ohio, 45404
United States
Toledo Children's Hospital
Toledo, Ohio, 43606
United States
Oklahoma Cystic Fibrosis Center
Oklahoma City, Oklahoma, 73104
United States
Oregon Health Sciences University
Portland, Oregon, 97239
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Vanderbilt Children's Hospital
Nashville, Tennessee, 37232
United States
University of Texas Southwestern / Children's Health
Dallas, Texas, 75207
United States
University of Texas Southwestern
Dallas, Texas, 75390
United States
Cook Children's Medical Center
Fort Worth, Texas, 76104
United States
Virginia Commonwealth University
Richmond, Virginia, 23219
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States
University of Washington Medical Center
Seattle, Washington, 98195
United States
Providence Medical Group, Cystic Fibrosis Clinic
Spokane, Washington, 99204
United States
West Virginia University - Morgantown
Morgantown, West Virginia, 26507
United States
University of Wisconsin
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Chris Goss

  • Patrick Flume, MD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-23
Study Completion Date2026-11-15

Study Record Updates

Study Start Date2023-04-23
Study Completion Date2026-11-15

Terms related to this study

Keywords Provided by Researchers

  • Cystic Fibrosis
  • CF
  • Cystic Fibrosis Pulmonary Exacerbation
  • aminoglycoside
  • beta-lactam
  • β-lactam
  • STOP
  • STOP360

Additional Relevant MeSH Terms

  • Cystic Fibrosis
  • Cystic Fibrosis Pulmonary Exacerbation