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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
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

Full criteria on ClinicalTrials.gov

Sites (60)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
University of Calgary Adult Cystic Fibrosis Clinic (Calgary, AB)
Coordinator of this site? Confirm its status
CalgaryCanadaRecruiting
Children's Hospital Medical Center of Akron
Coordinator of this site? Confirm its status
AkronUnited StatesRecruiting
University of Michigan - Michigan Medicine
Coordinator of this site? Confirm its status
Ann ArborUnited StatesRecruiting
Emory University
Coordinator of this site? Confirm its status
AtlantaUnited StatesRecruiting
John Hopkins Hospital
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting
Billings Clinic
Coordinator of this site? Confirm its status
BillingsUnited StatesRecruiting
The Children's Hospital Alabama & University of Alabama at Birmingham
Coordinator of this site? Confirm its status
BirminghamUnited StatesRecruiting
Saint Luke's Cystic Fibrosis Center of Idaho
Coordinator of this site? Confirm its status
BoiseUnited StatesRecruiting
Boston Children's Hospital, Brigham & Women's Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Medical University of South Carolina
Coordinator of this site? Confirm its status
CharlestonUnited StatesRecruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
Northwestern University
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
Cincinnati Children's Hospital Medical Center
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CincinnatiUnited StatesRecruiting
University of Cincinnati Medical Center
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CincinnatiUnited StatesRecruiting
Rainbow Babies and Children's Hospital / University Hospitals Cleveland Medical Center
Coordinator of this site? Confirm its status
ClevelandUnited StatesRecruiting
Nationwide Children's Hospital
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting
University of Texas, Southwestern
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting
University of Texas Southwestern, Children's Health
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting
Dayton Children's Hospital
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DaytonUnited StatesRecruiting
Cook Children's Medical Center
Coordinator of this site? Confirm its status
Fort WorthUnited StatesRecruiting
University of Florida
Coordinator of this site? Confirm its status
GainesvilleUnited StatesRecruiting
Helen DeVos Children's Hospital
Coordinator of this site? Confirm its status
Grand RapidsUnited StatesRecruiting
Joe DiMaggio Children's Hospital
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HollywoodUnited StatesRecruiting
Riley Hospital for Children
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IndianapolisUnited StatesRecruiting
Indiana University Medical Center
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IndianapolisUnited StatesRecruiting
University of Iowa
Coordinator of this site? Confirm its status
Iowa CityUnited StatesRecruiting
Nemours Children's Clinic
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesRecruiting
University of Kansas Medical Center
Coordinator of this site? Confirm its status
Kansas CityUnited StatesRecruiting
University of California San Diego
Coordinator of this site? Confirm its status
La JollaUnited StatesRecruiting
Dartmouth Hitchcock Medical Center
Coordinator of this site? Confirm its status
LebanonUnited StatesRecruiting
Long Beach Memorial Medical Center
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Long BeachUnited StatesRecruiting
University of Louisville
Coordinator of this site? Confirm its status
LouisvilleUnited StatesRecruiting
University of Wisconsin
Coordinator of this site? Confirm its status
MadisonUnited StatesRecruiting
University of Miami
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting
West Virginia University - Morgantown
Coordinator of this site? Confirm its status
MorgantownUnited StatesRecruiting
Morristown Medical Center
Coordinator of this site? Confirm its status
MorristownUnited StatesRecruiting
Vanderbilt Children's Hospital
Coordinator of this site? Confirm its status
NashvilleUnited StatesRecruiting
Rutgers, Robert Wood Johnson Medical School
Coordinator of this site? Confirm its status
New BrunswickUnited StatesRecruiting
Children's Hospital of New York
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Lenox Hill Hospital Cystic Fibrosis Center
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Oklahoma Cystic Fibrosis Center
Coordinator of this site? Confirm its status
Oklahoma CityUnited StatesRecruiting
CHOC Children's Hospital
Coordinator of this site? Confirm its status
OrangeUnited StatesRecruiting
OSF Saint Francis Medical Center
Coordinator of this site? Confirm its status
PeoriaUnited StatesRecruiting
University of Pennsylvania
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
Children's Hospital of Pittsburgh of UPMC
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PittsburghUnited StatesRecruiting
Maine Medical Center
Coordinator of this site? Confirm its status
PortlandUnited StatesRecruiting
Oregon Health Sciences University
Coordinator of this site? Confirm its status
PortlandUnited StatesRecruiting
Virginia Commonwealth University
Coordinator of this site? Confirm its status
RichmondUnited StatesRecruiting
University of California at Davis Medical Center
Coordinator of this site? Confirm its status
SacramentoUnited StatesRecruiting
Seattle Children's Hospital
Coordinator of this site? Confirm its status
SeattleUnited StatesRecruiting
University of Washington Medical Center
Coordinator of this site? Confirm its status
SeattleUnited StatesRecruiting
Providence Medical Group, Cystic Fibrosis Clinic
Coordinator of this site? Confirm its status
SpokaneUnited StatesRecruiting
Washington University School of Medicine
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting
SSM Health Cardinal Glennon Children's Hospital
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting
All Children's Hospital
Coordinator of this site? Confirm its status
St. PetersburgUnited StatesRecruiting
Toledo Children's Hospital
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ToledoUnited StatesRecruiting
Tucson Cystic Fibrosis Center
Coordinator of this site? Confirm its status
TucsonUnited StatesRecruiting
New York Medical College at Westchester Medical Center
Coordinator of this site? Confirm its status
ValhallaUnited StatesRecruiting
Children's National Medical Center
Coordinator of this site? Confirm its status
Washington D.C.United StatesNot yet recruiting
University of Massachusetts Memorial Health Care
Coordinator of this site? Confirm its status
WorcesterUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.