Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study

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: * 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 Overview

Study Details

Study overview

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?

Standardizing Treatments for Pulmonary Exacerbations: A Platform for Evaluating Treatment Decisions to Improve Outcomes (STOP360) Aminoglycoside Study (AG Study)

Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study

Condition
Cystic Fibrosis
Intervention / Treatment

-

Contacts and Locations

Birmingham

The Children's Hospital Alabama, University of Alabama at Birmingham, Birmingham, Alabama, United States, 35233

Tucson

Tucson Cystic Fibrosis Center, Tucson, Arizona, United States, 85724

La Jolla

University of California San Diego, La Jolla, California, United States, 92093

Long Beach

Long Beach Memorial Medical Center, Long Beach, California, United States, 90806

Orange

CHOC Children's Hospital, Orange, California, United States, 92868

Sacramento

University of California at Davis Medical Center, Sacramento, California, United States, 95817

Washington

Children's National Medical Center, Washington, District of Columbia, United States, 20010

Gainesville

University of Florida, Gainesville, Florida, United States, 32610

Hollywood

Joe DiMaggio Children's Hospital, Hollywood, Florida, United States, 33021

Jacksonville

Nemours Children's Clinic, Jacksonville, Florida, United States, 32207

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

6 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Chris Goss,

Patrick Flume, MD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

2026-11-15