Compares two antibiotic treatments for lung flare-ups in cystic fibrosis
Compares one antibiotic type with two types for cystic fibrosis lung flare-ups.
Plain-language title generated from the registry record
Registry title: Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study
Key facts
- Where
- Akron, Ann Arbor, Atlanta, Baltimore, Billings, Birmingham, Boise, Boston, Charleston, Chicago, Cincinnati, Cleveland, Columbus, Dallas, Dayton, Fort Worth, Gainesville, Grand Rapids, Hollywood, Indianapolis, Iowa City, Jacksonville, Kansas City, La Jolla, Lebanon, Long Beach, Louisville, Madison, Miami, Morgantown, Morristown, Nashville, New Brunswick, New York, Oklahoma City, Orange, Peoria, Philadelphia, Pittsburgh, Portland, Richmond, Sacramento, Seattle, Spokane, St Louis, St. Petersburg, Toledo, Tucson, Valhalla, Washington D.C., and Worcester, United StatesSee the 59 sites
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 6 or older with cystic fibrosis who have a lung flare-up and will get 14 days of IV antibiotics.
- Age
- 6 years or older
- Sex
- All genders can join
- Disease stage
- A cystic fibrosis lung flare-up (pulmonary exacerbation) that the doctor plans to treat with a 14-day course of IV antibiotics
- Earlier treatment
- No IV antibiotics, ICU stay, pneumothorax or coughing up blood within 6 weeks before Visit 1. No investigational therapies, new CFTR modulators or treatment for nontuberculous mycobacteria (NTM) within 4 weeks before Visit 1. No more than one day of IV aminoglycosides for the current flare-up before Visit 1.
- Biomarker or test result
- At least one documented Pa positive culture within two years before Visit 1
Main reasons for not taking part
- Pregnancy
- Known kidney problems or a past solid organ transplant
- History of allergy, balance or hearing damage from aminoglycosides
- Use of investigational therapies or new CFTR modulators within 4 weeks before Visit 1
- More than one day of IV aminoglycosides for the current flare-up before Visit 1
Read by machine on 9 November 2026.
Where in United States
- Children's Hospital Medical Center of AkronAkron, United StatesTaking people
- University of Michigan - Michigan MedicineAnn Arbor, United StatesTaking people
- Emory UniversityAtlanta, United StatesTaking people
- John Hopkins HospitalBaltimore, United StatesTaking people
- Billings ClinicBillings, United StatesTaking people
- The Children's Hospital Alabama & University of Alabama at BirminghamBirmingham, United StatesTaking people
- Saint Luke's Cystic Fibrosis Center of IdahoBoise, United StatesTaking people
- Boston Children's Hospital, Brigham & Women's HospitalBoston, United StatesTaking people
- Medical University of South CarolinaCharleston, United StatesTaking people
- Ann & Robert H. Lurie Children's Hospital of ChicagoChicago, United StatesTaking people
- Northwestern UniversityChicago, United StatesTaking people
- Cincinnati Children's Hospital Medical CenterCincinnati, United StatesTaking people
- University of Cincinnati Medical CenterCincinnati, United StatesTaking people
- Rainbow Babies and Children's Hospital / University Hospitals Cleveland Medical CenterCleveland, United StatesTaking people
- Nationwide Children's HospitalColumbus, United StatesTaking people
- University of Texas Southwestern, Children's HealthDallas, United StatesTaking people
- University of Texas, SouthwesternDallas, United StatesTaking people
- Dayton Children's HospitalDayton, United StatesTaking people
- Cook Children's Medical CenterFort Worth, United StatesTaking people
- University of FloridaGainesville, United StatesTaking people
- Helen DeVos Children's HospitalGrand Rapids, United StatesTaking people
- Joe DiMaggio Children's HospitalHollywood, United StatesTaking people
- Indiana University Medical CenterIndianapolis, United StatesTaking people
- Riley Hospital for ChildrenIndianapolis, United StatesTaking people
- University of IowaIowa City, United StatesTaking people
- Nemours Children's ClinicJacksonville, United StatesTaking people
- University of Kansas Medical CenterKansas City, United StatesTaking people
- University of California San DiegoLa Jolla, United StatesTaking people
- Dartmouth Hitchcock Medical CenterLebanon, United StatesTaking people
- Long Beach Memorial Medical CenterLong Beach, United StatesTaking people
- University of LouisvilleLouisville, United StatesTaking people
- University of WisconsinMadison, United StatesTaking people
- University of MiamiMiami, United StatesTaking people
- West Virginia University - MorgantownMorgantown, United StatesTaking people
- Morristown Medical CenterMorristown, United StatesTaking people
- Vanderbilt Children's HospitalNashville, United StatesTaking people
- Rutgers, Robert Wood Johnson Medical SchoolNew Brunswick, United StatesTaking people
- Children's Hospital of New YorkNew York, United StatesTaking people
- Lenox Hill Hospital Cystic Fibrosis CenterNew York, United StatesTaking people
- Oklahoma Cystic Fibrosis CenterOklahoma City, United StatesTaking people
- CHOC Children's HospitalOrange, United StatesTaking people
- OSF Saint Francis Medical CenterPeoria, United StatesTaking people
- University of PennsylvaniaPhiladelphia, United StatesTaking people
- Children's Hospital of Pittsburgh of UPMCPittsburgh, United StatesTaking people
- Maine Medical CenterPortland, United StatesTaking people
- Oregon Health Sciences UniversityPortland, United StatesTaking people
- Virginia Commonwealth UniversityRichmond, United StatesTaking people
- University of California at Davis Medical CenterSacramento, United StatesTaking people
- Seattle Children's HospitalSeattle, United StatesTaking people
- University of Washington Medical CenterSeattle, United StatesTaking people
- Providence Medical Group, Cystic Fibrosis ClinicSpokane, United StatesTaking people
- SSM Health Cardinal Glennon Children's HospitalSt Louis, United StatesTaking people
- Washington University School of MedicineSt Louis, United StatesTaking people
- All Children's HospitalSt. Petersburg, United StatesTaking people
- Toledo Children's HospitalToledo, United StatesTaking people
- Tucson Cystic Fibrosis CenterTucson, United StatesTaking people
- New York Medical College at Westchester Medical CenterValhalla, United StatesTaking people
- Children's National Medical CenterWashington D.C., United StatesNot yet recruiting
- University of Massachusetts Memorial Health CareWorcester, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chris Goss
- Trial code
- NCT05548283
- Record updated
- 8 July 2026
- Original 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:Read full original descriptionShow less
Standardizing Treatments for Pulmonary Exacerbations: A Platform for Evaluating Treatment Decisions to Improve Outcomes (STOP360) Aminoglycoside Study (AG Study)
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?
Inclusion: 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.
Exclusion: 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; No known renal impairment or history of solid organ transplantation; No history of hypersensitivity, vestibular, or auditory toxicity with aminoglycosides; Participant is not pregnant.