Recruiting

Aminoglycoside

Sponsor:

Chris Goss

Code:

NCT05548283

Conditions

Cystic Fibrosis

Cystic Fibrosis Pulmonary Exacerbation

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

Interventions

Beta-lactam antibiotic

Aminoglycoside

Study Details

Brief 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?

Conditions

Cystic Fibrosis

Cystic Fibrosis Pulmonary Exacerbation

Study ID

NCT05548283

Start date

Apr 23, 2023

Status verified date

Jul, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • Participant is not pregnant
  • No known renal impairment or history of solid organ transplantation
  • 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 history of hypersensitivity, vestibular, or auditory toxicity with aminoglycosides
  • No more than one day of IV aminoglycosides administered for the current PEx treatment prior to Visit 1

Study Design

Enrollment

730 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Beta-lactam antibiotic

Intravenous (IV) β-lactam will be selected by the treating physician following standard of care. Treatment will last for 14 days (± 2 days).

Aminoglycoside

Intravenous (IV) aminoglycoside will be selected by the treating physician following standard of care. Treatment will last for 14 days (± 2 days).

Primary outcome measure

  • Absolute Change in FEV1 % Predicted at Week 4 in Aminoglycoside (AG) Study [ Time Frame: Four weeks ]
  • Incidence of Adverse Events (AEs) in Aminoglycoside (AG) Study Intervention Arms [ Time Frame: Six Weeks ]

Central Contacts and Locations

Central contacts

Rachael Buckingham, BS

206-884-7517Rachael.buckingham@seattlechildrens.org

Barbra Fogarty

206-884-7592Barbra.fogarty@seattlechildrens.org

Locations

The Children's Hospital Alabama, University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Heather Hathorne

hyhathorne@uabmc.edu

Tucson Cystic Fibrosis Center

Recruiting

Tucson, Arizona, United States, 85724

Contacts

Elizabeth Ryan

elizabethryan@email.arizona.edu

University of California San Diego

Recruiting

La Jolla, California, United States, 92093

Contacts

Jenna Mielke,

jmielke@health.ucsd.edu

Long Beach Memorial Medical Center

Recruiting

Long Beach, California, United States, 90806

Contacts

Marylee Melendrez

mmelendrez@memorialcare.org

CHOC Children's Hospital

Recruiting

Orange, California, United States, 92868

Contacts

Lila Klein

Lila.klein@choc.org

University of California at Davis Medical Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Daniel Diaz-Vigil

ddiazvigil@ucdavis.edu

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Melissa Lingis

melissa.lingis@peds.ufl.edu

Joe DiMaggio Children's Hospital

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Norma (Jean) Barton

nbarton@mhs.net

Nemours Children's Clinic

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Jennifer (Jenn) Gafford

Jennifer.gafford@nemours.org

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Ylber Whitaker

yiw2@miami.edu

All Children's Hospital

Recruiting

St. Petersburg, Florida, United States, 33701

Contacts

Diana Hodge

dhodge6@jhmi.edu

Emory University

Recruiting

Atlanta, Georgia, United States, 30327

Contacts

Ashleigh Streby

ashleigh.streby@emory.edu

Saint Luke's Cystic Fibrosis Center of Idaho

Recruiting

Boise, Idaho, United States, 83702

Contacts

Lejla Godusevic

godusevl@slhs.org

Ann & Robert H. Lurie Children's Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Yung Hsuan (Irene) Wu

yhwu@luriechildrens.org

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Rachel Nelson

rachel.nelson@northwestern.edu

OSF Saint Francis Medical Center

Recruiting

Peoria, Illinois, United States, 61637

Contacts

Ashley Scott

Ashley.Scott@osfhealthcare.org

Indiana University Medical Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Lisa Bendy

lbendy@iu.edu

Riley Hospital for Children

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Lisa Bendy

lbendy@iupui.edu

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Mary Teresi

mary-teresi@uiowa.edu

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Lawrence Scott

lscott2@kumc.edu

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Melissa Thomas

mcthom12@louisville.edu

Maine Medical Center

Recruiting

Portland, Maine, United States, 04102

Contacts

Harmony Renna

Harmony.Renna@mainehealth.org

John Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Jeanne Pinto

jpinto4@jh.edu

Boston Children's Hospital, Brigham & Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Robert Fowler

Robert.fowler@childrens.harvard.edu

University of Massachusetts Memorial Health Care

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Jaclyn Longtine

Jaclyn.Longtine@umassmed.edu

University of Michigan, Michigan Medicine

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Dawn Kruse

dmkruse@med.umich.edu

Helen DeVos Children's Hospital

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

Andrew James

andrew.james@corewellhealth.org

SSM Health Cardinal Glennon Children's Hospital

Recruiting

St Louis, Missouri, United States, 63104

Contacts

Freda Branch

freda.branch@health.slu.edu

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Irma Bauer

irmabauer@wustl.edu

Billings Clinic

Recruiting

Billings, Montana, United States, 59101

Contacts

Jerimiah Lysinger

JLysinger@billingsclinic.org

Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Barbara A Rodgers

Barbara.A.Rodgers@hitchcock.org

Morristown Medical Center

Recruiting

Morristown, New Jersey, United States, 07960

Contacts

Debra Connolly

Debra.Connolly@atlantichealth.org

Rutgers - Robert Wood Johnson Medical School

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

Sheila Redding, Sheila

sr1238@rwjms.rutgers.edu

Lenox Hill Hospital Cystic Fibrosis Center

Recruiting

New York, New York, United States, 10003

Contacts

Teresa Demarco

Tdemarco3@northwell.edu

Children's Hospital of New York

Recruiting

New York, New York, United States, 10032

Contacts

Hossein Sadeghi

HS762@cumc.Columbia.edu

New York Medical College at Westchester Medical Center

Recruiting

Valhalla, New York, United States, 10595

Contacts

Zachary Messer

Zachary_Messer@nymc.edu

Children's Hospital Medical Center of Akron

Recruiting

Akron, Ohio, United States, 44308

Contacts

Michelle Parrish

MParrish@akronchildrens.org

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Kelly Thornton

Kelly.Thornton@cchmc.org

University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Nicole Hummel

Nicole.Hummel@UCHealth.com

Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44146

Contacts

Primary RC & Participant Contact General Contact

RainbowCFResearch@UHhospitals.org

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Diana Gilmore

Diana.Gilmore@nationwidechildrens.org

Dayton Children's Hospital

Recruiting

Dayton, Ohio, United States, 45404

Contacts

Amy Jones

Jonesa11@childrensdayton.org

Toledo Children's Hospital

Recruiting

Toledo, Ohio, United States, 43606

Contacts

Kelly Hoot

kelly.hoot@promedica.org

Oklahoma Cystic Fibrosis Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

CF Center Participant Contact

cfresearchteam@ouhsc.edu

Oregon Health Sciences University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Jenna Bucher

bucherj@ohsu.edu

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Melissa Molter

melissa.molter@pennmedicine.upenn.edu

Children's Hospital of Pittsburgh of UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Elizabeth Hartigan

elizabeth.hartigan@chp.edu

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Ashley Warden

jonesash@musc.edu

Vanderbilt Children's Hospital

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Brijesh Patel

brijesh.patel@vumc.org

University of Texas Southwestern / Children's Health

Recruiting

Dallas, Texas, United States, 75207

Contacts

Mary Klosterman

Mary.Klosterman@UTSouthwestern.edu

University of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75390

Contacts

Ashley Keller

Ashley.Keller@UTSouthwestern.edu

Cook Children's Medical Center

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Jill Finto

jill.finto@cookchildrens.org

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23219

Contacts

Akilah Pierre-Louis

akilah.pierrelouis1@vcuhealth.org

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Sharon McNamara

sharon.mcnamara@seattlechildrens.org

University of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98195

Contacts

Lauren Bartlett

lrejman@uw.edu

Providence Medical Group, Cystic Fibrosis Clinic

Recruiting

Spokane, Washington, United States, 99204

Contacts

Joan Milton

joan.milton@providence.org

West Virginia University - Morgantown

Recruiting

Morgantown, West Virginia, United States, 26507

Contacts

Tammy Clark

tclark@hsc.wvu.edu

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Melanie Nelson

mnelson@pediatrics.wisc.edu

University of Calgary Adult Cystic Fibrosis Clinic (Calgary, AB)

Recruiting

Calgary, Alberta, Canada, T2N4N1

Contacts

Clare Smith

Clare.smith@albertahealthservices.ca

More Information

Sponsor

Chris Goss

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-06. This information was provided to ClinicalTrials.gov by Chris Goss on 2026-07-08.