Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study

Purpose

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

Eligibility

Eligible Ages
Over 6 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
The aminoglycoside study will compare treatment of an IV β-lactam and aminoglycoside (AG) versus an IV β-lactam only (non-AG). Individuals will be randomly assigned in a 1:1 fashion to receive either the AG or non-AG intervention for a planned 14 day course of IV antibiotics. IV antibiotic treatments for each intervention arm will be selected by the treating physician following standard of care.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: 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).
    Other names:
    • β-lactam
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.
  • Drug: 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).
    Other names:
    • β-lactam
  • Drug: Aminoglycoside
    Intravenous (IV) aminoglycoside will be selected by the treating physician following standard of care. Treatment will last for 14 days (± 2 days).
    Other names:
    • AG

Recruiting Locations

The Children's Hospital Alabama, University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764 35233
Contact:
Heather Hathorne
hyhathorne@uabmc.edu

Tucson Cystic Fibrosis Center
Tucson 5318313, Arizona 5551752 85724
Contact:
Elizabeth Ryan
elizabethryan@email.arizona.edu

University of California San Diego
La Jolla 5363943, California 5332921 92093
Contact:
Jenna Mielke,
jmielke@health.ucsd.edu

Long Beach Memorial Medical Center
Long Beach 5367929, California 5332921 90806
Contact:
Marylee Melendrez
mmelendrez@memorialcare.org

CHOC Children's Hospital
Orange 5379513, California 5332921 92868
Contact:
Lila Klein
Lila.klein@choc.org

University of California at Davis Medical Center
Sacramento 5389489, California 5332921 95817
Contact:
Daniel Diaz-Vigil
ddiazvigil@ucdavis.edu

University of Florida
Gainesville 4156404, Florida 4155751 32610
Contact:
Melissa Lingis
melissa.lingis@peds.ufl.edu

Joe DiMaggio Children's Hospital
Hollywood 4158928, Florida 4155751 33021
Contact:
Norma (Jean) Barton
nbarton@mhs.net

Nemours Children's Clinic
Jacksonville 4160021, Florida 4155751 32207
Contact:
Jennifer (Jenn) Gafford
Jennifer.gafford@nemours.org

University of Miami
Miami 4164138, Florida 4155751 33136
Contact:
Ylber Whitaker
yiw2@miami.edu

All Children's Hospital
St. Petersburg 4171563, Florida 4155751 33701
Contact:
Diana Hodge
dhodge6@jhmi.edu

Emory University
Atlanta 4180439, Georgia 4197000 30327
Contact:
Ashleigh Streby
ashleigh.streby@emory.edu

Saint Luke's Cystic Fibrosis Center of Idaho
Boise 5586437, Idaho 5596512 83702
Contact:
Lejla Godusevic
godusevl@slhs.org

Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago 4887398, Illinois 4896861 60611
Contact:
Yung Hsuan (Irene) Wu
yhwu@luriechildrens.org

Northwestern University
Chicago 4887398, Illinois 4896861 60611
Contact:
Rachel Nelson
rachel.nelson@northwestern.edu

OSF Saint Francis Medical Center
Peoria 4905687, Illinois 4896861 61637
Contact:
Ashley Scott
Ashley.Scott@osfhealthcare.org

Indiana University Medical Center
Indianapolis 4259418, Indiana 4921868 46202
Contact:
Lisa Bendy
lbendy@iu.edu

Riley Hospital for Children
Indianapolis 4259418, Indiana 4921868 46202
Contact:
Lisa Bendy
lbendy@iupui.edu

University of Iowa
Iowa City 4862034, Iowa 4862182 52242
Contact:
Mary Teresi
mary-teresi@uiowa.edu

University of Kansas Medical Center
Kansas City 4273837, Kansas 4273857 66160
Contact:
Lawrence Scott
lscott2@kumc.edu

University of Louisville
Louisville 4299276, Kentucky 6254925 40202
Contact:
Melissa Thomas
mcthom12@louisville.edu

Maine Medical Center
Portland 4975802, Maine 4971068 04102
Contact:
Harmony Renna
Harmony.Renna@mainehealth.org

John Hopkins Hospital
Baltimore 4347778, Maryland 4361885 21205
Contact:
Jeanne Pinto
jpinto4@jh.edu

Boston Children's Hospital, Brigham & Women's Hospital
Boston 4930956, Massachusetts 6254926 02115
Contact:
Robert Fowler
Robert.fowler@childrens.harvard.edu

University of Massachusetts Memorial Health Care
Worcester 4956184, Massachusetts 6254926 01655
Contact:
Jaclyn Longtine
Jaclyn.Longtine@umassmed.edu

University of Michigan, Michigan Medicine
Ann Arbor 4984247, Michigan 5001836 48109
Contact:
Dawn Kruse
dmkruse@med.umich.edu

Helen DeVos Children's Hospital
Grand Rapids 4994358, Michigan 5001836 49546
Contact:
Andrew James
andrew.james@corewellhealth.org

SSM Health Cardinal Glennon Children's Hospital
St Louis 4407066, Missouri 4398678 63104
Contact:
Freda Branch
freda.branch@health.slu.edu

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
Contact:
Irma Bauer
irmabauer@wustl.edu

Billings Clinic
Billings 5640350, Montana 5667009 59101
Contact:
Jerimiah Lysinger
JLysinger@billingsclinic.org

Dartmouth Hitchcock Medical Center
Lebanon 5088597, New Hampshire 5090174 03756
Contact:
Barbara A Rodgers
Barbara.A.Rodgers@hitchcock.org

Morristown Medical Center
Morristown 5101427, New Jersey 5101760 07960
Contact:
Debra Connolly
Debra.Connolly@atlantichealth.org

Rutgers - Robert Wood Johnson Medical School
New Brunswick 5101717, New Jersey 5101760 08903
Contact:
Sheila Redding, Sheila
sr1238@rwjms.rutgers.edu

Lenox Hill Hospital Cystic Fibrosis Center
New York 5128581, New York 5128638 10003
Contact:
Teresa Demarco
Tdemarco3@northwell.edu

Children's Hospital of New York
New York 5128581, New York 5128638 10032
Contact:
Hossein Sadeghi
HS762@cumc.Columbia.edu

New York Medical College at Westchester Medical Center
Valhalla 5142090, New York 5128638 10595
Contact:
Zachary Messer
Zachary_Messer@nymc.edu

Children's Hospital Medical Center of Akron
Akron 5145476, Ohio 5165418 44308
Contact:
Michelle Parrish
MParrish@akronchildrens.org

Cincinnati Children's Hospital Medical Center
Cincinnati 4508722, Ohio 5165418 45229
Contact:
Kelly Thornton
Kelly.Thornton@cchmc.org

University of Cincinnati Medical Center
Cincinnati 4508722, Ohio 5165418 45267
Contact:
Nicole Hummel
Nicole.Hummel@UCHealth.com

Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44146
Contact:
Primary RC & Participant Contact General Contact
RainbowCFResearch@UHhospitals.org

Nationwide Children's Hospital
Columbus 4509177, Ohio 5165418 43205
Contact:
Diana Gilmore
Diana.Gilmore@nationwidechildrens.org

Dayton Children's Hospital
Dayton 4509884, Ohio 5165418 45404
Contact:
Amy Jones
Jonesa11@childrensdayton.org

Toledo Children's Hospital
Toledo 5174035, Ohio 5165418 43606
Contact:
Kelly Hoot
kelly.hoot@promedica.org

Oklahoma Cystic Fibrosis Center
Oklahoma City 4544349, Oklahoma 4544379 73104
Contact:
CF Center Participant Contact
cfresearchteam@ouhsc.edu

Oregon Health Sciences University
Portland 5746545, Oregon 5744337 97239
Contact:
Jenna Bucher
bucherj@ohsu.edu

University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
Contact:
Melissa Molter
melissa.molter@pennmedicine.upenn.edu

Children's Hospital of Pittsburgh of UPMC
Pittsburgh 5206379, Pennsylvania 6254927 15224
Contact:
Elizabeth Hartigan
elizabeth.hartigan@chp.edu

Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425
Contact:
Ashley Warden
jonesash@musc.edu

Vanderbilt Children's Hospital
Nashville 4644585, Tennessee 4662168 37232
Contact:
Brijesh Patel
brijesh.patel@vumc.org

University of Texas Southwestern / Children's Health
Dallas 4684888, Texas 4736286 75207
Contact:
Mary Klosterman
Mary.Klosterman@UTSouthwestern.edu

University of Texas Southwestern
Dallas 4684888, Texas 4736286 75390
Contact:
Ashley Keller
Ashley.Keller@UTSouthwestern.edu

Cook Children's Medical Center
Fort Worth 4691930, Texas 4736286 76104
Contact:
Jill Finto
jill.finto@cookchildrens.org

Virginia Commonwealth University
Richmond 4781708, Virginia 6254928 23219
Contact:
Akilah Pierre-Louis
akilah.pierrelouis1@vcuhealth.org

Seattle Children's Hospital
Seattle 5809844, Washington 5815135 98105
Contact:
Sharon McNamara
sharon.mcnamara@seattlechildrens.org

University of Washington Medical Center
Seattle 5809844, Washington 5815135 98195
Contact:
Lauren Bartlett
lrejman@uw.edu

Providence Medical Group, Cystic Fibrosis Clinic
Spokane 5811696, Washington 5815135 99204
Contact:
Joan Milton
joan.milton@providence.org

West Virginia University - Morgantown
Morgantown 4815352, West Virginia 4826850 26507
Contact:
Tammy Clark
tclark@hsc.wvu.edu

University of Wisconsin
Madison 5261457, Wisconsin 5279468 53792
Contact:
Melanie Nelson
mnelson@pediatrics.wisc.edu

More Details

NCT ID
NCT05548283
Status
Recruiting
Sponsor
Chris Goss

Study Contact

Rachael Buckingham, BS
206-884-7517
Rachael.buckingham@seattlechildrens.org

Detailed Description

Cystic Fibrosis Foundation (CFF) treatment guidelines for the management of pulmonary exacerbations (PEx) identified evidence gaps in current clinical best practices. The STOP program offers a platform for the conduct of controlled trials to develop the evidence base in order to define clinical best practices. The interventional Aminoglycoside Study (AG Study) will be a prospective, multi-center, parallel group, randomized (1:1 ratio), open-label, superiority study of intravenous aminoglycoside and β-lactams versus intravenous β-lactams only. Randomization will occur at Visit 1. The primary objective of this platform trial is to evaluate the efficacy and safety of differing treatments in CF PEx during a planned 14 day course of IV antimicrobials. Primary efficacy will be evaluated as the difference in mean Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) changes from Visit 1 to Visit 2 (Day 28 ± 2 days) between intervention arms.

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