NCT05548283RecruitingPhase 4
Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study
Standardizing Treatments for Pulmonary Exacerbations: A Platform for Evaluating Treatment Decisions to Improve Outcomes (STOP360) Aminoglycoside Study (AG Study)
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
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?
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 730 (estimated)
- First submitted
- 16 Sept 2022
- Start date
- 23 Apr 2023
- Primary completion date
- 31 May 2027
- Lead sponsor
- Chris Goss
- Diseases
- Cystic fibrosis
- NCT number
- NCT05548283
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 730
- From 23 Apr 2023 to the primary completion date, 31 May 2027
- 60 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- No IV antimicrobial treatment, ICU admission, pneumothorax, or hemoptysis within 6 weeks prior to Visit 1
- 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
- No more than one day of IV aminoglycosides administered for the current PEx treatment prior to Visit 1
Other illness
- No known renal impairment or history of solid organ transplantation
- No history of hypersensitivity, vestibular, or auditory toxicity with aminoglycosides
Other
- Participant is not pregnant
Who the study is looking for
- 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
Age in the registry: 6 years to - · Sex: All · Does not accept healthy volunteers
Sites (60)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Calgary Adult Cystic Fibrosis Clinic (Calgary, AB) Coordinator of this site? Confirm its status | Calgary | Canada | Recruiting |
| Children's Hospital Medical Center of Akron Coordinator of this site? Confirm its status | Akron | United States | Recruiting |
| University of Michigan - Michigan Medicine Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| John Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Billings Clinic Coordinator of this site? Confirm its status | Billings | United States | Recruiting |
| The Children's Hospital Alabama & University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Saint Luke's Cystic Fibrosis Center of Idaho Coordinator of this site? Confirm its status | Boise | United States | Recruiting |
| Boston Children's Hospital, Brigham & Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| Ann & Robert H. Lurie Children's Hospital of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| University of Cincinnati Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Rainbow Babies and Children's Hospital / University Hospitals Cleveland Medical Center Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Nationwide Children's Hospital Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| University of Texas, Southwestern Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| University of Texas Southwestern, Children's Health Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Dayton Children's Hospital Coordinator of this site? Confirm its status | Dayton | United States | Recruiting |
| Cook Children's Medical Center Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Recruiting |
| Helen DeVos Children's Hospital Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| Joe DiMaggio Children's Hospital Coordinator of this site? Confirm its status | Hollywood | United States | Recruiting |
| Riley Hospital for Children Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| Indiana University Medical Center Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| University of Iowa Coordinator of this site? Confirm its status | Iowa City | United States | Recruiting |
| Nemours Children's Clinic Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| University of California San Diego Coordinator of this site? Confirm its status | La Jolla | United States | Recruiting |
| Dartmouth Hitchcock Medical Center Coordinator of this site? Confirm its status | Lebanon | United States | Recruiting |
| Long Beach Memorial Medical Center Coordinator of this site? Confirm its status | Long Beach | United States | Recruiting |
| University of Louisville Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| University of Wisconsin Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| West Virginia University - Morgantown Coordinator of this site? Confirm its status | Morgantown | United States | Recruiting |
| Morristown Medical Center Coordinator of this site? Confirm its status | Morristown | United States | Recruiting |
| Vanderbilt Children's Hospital Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Rutgers, Robert Wood Johnson Medical School Coordinator of this site? Confirm its status | New Brunswick | United States | Recruiting |
| Children's Hospital of New York Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Lenox Hill Hospital Cystic Fibrosis Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Oklahoma Cystic Fibrosis Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| CHOC Children's Hospital Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| OSF Saint Francis Medical Center Coordinator of this site? Confirm its status | Peoria | United States | Recruiting |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Children's Hospital of Pittsburgh of UPMC Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Maine Medical Center Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Oregon Health Sciences University Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Virginia Commonwealth University Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| University of California at Davis Medical Center Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| Seattle Children's Hospital Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| University of Washington Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Providence Medical Group, Cystic Fibrosis Clinic Coordinator of this site? Confirm its status | Spokane | United States | Recruiting |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| SSM Health Cardinal Glennon Children's Hospital Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| All Children's Hospital Coordinator of this site? Confirm its status | St. Petersburg | United States | Recruiting |
| Toledo Children's Hospital Coordinator of this site? Confirm its status | Toledo | United States | Recruiting |
| Tucson Cystic Fibrosis Center Coordinator of this site? Confirm its status | Tucson | United States | Recruiting |
| New York Medical College at Westchester Medical Center Coordinator of this site? Confirm its status | Valhalla | United States | Recruiting |
| Children's National Medical Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Not yet recruiting |
| University of Massachusetts Memorial Health Care Coordinator of this site? Confirm its status | Worcester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.