Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study (STOP360AG)

April 24, 2024 updated by: Chris Goss

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

730

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
    • Ontario
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • The Children's Hospital Alabama, University of Alabama at Birmingham
        • Contact:
    • Arizona
    • California
      • La Jolla, California, United States, 92093
      • Long Beach, California, United States, 90806
      • Orange, California, United States, 92868
      • Sacramento, California, United States, 95817
        • Not yet recruiting
        • University of California at Davis Medical Center
        • Contact:
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Florida
      • Gainesville, Florida, United States, 32610
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Joe DiMaggio Children's Hospital
        • Contact:
      • Jacksonville, Florida, United States, 32207
      • Miami, Florida, United States, 33136
        • Not yet recruiting
        • University of Miami
        • Contact:
      • Saint Petersburg, Florida, United States, 33701
        • Recruiting
        • All Children's Hospital
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30327
    • Idaho
      • Boise, Idaho, United States, 83702
        • Recruiting
        • Saint Luke's Cystic Fibrosis Center of Idaho
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Ann & Robert H. Lurie Children's Hospital of Chicago
        • Contact:
      • Chicago, Illinois, United States, 60611
      • Peoria, Illinois, United States, 61637
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Riley Hospital for Children
        • Contact:
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Medical Center
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Contact:
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Maine
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • John Hopkins Hospital
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
      • Worcester, Massachusetts, United States, 01655
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
      • Grand Rapids, Michigan, United States, 49546
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
      • Saint Louis, Missouri, United States, 63104
    • Montana
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
    • New Jersey
      • Morristown, New Jersey, United States, 07960
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers - Robert Wood Johnson Medical School
        • Contact:
    • New York
      • New York, New York, United States, 10003
      • New York, New York, United States, 10032
      • Valhalla, New York, United States, 10595
        • Recruiting
        • New York Medical College at Westchester Medical Center
        • Contact:
    • Ohio
      • Akron, Ohio, United States, 44308
      • Cincinnati, Ohio, United States, 45229
      • Cincinnati, Ohio, United States, 45267
      • Cleveland, Ohio, United States, 44146
        • Recruiting
        • Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
        • Contact:
      • Columbus, Ohio, United States, 43205
      • Dayton, Ohio, United States, 45404
      • Toledo, Ohio, United States, 43606
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health Sciences University
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Pittsburgh, Pennsylvania, United States, 15224
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37232
    • Texas
    • Virginia
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington Medical Center
        • Contact:
      • Seattle, Washington, United States, 98105
      • Spokane, Washington, United States, 99204
    • West Virginia
      • Morgantown, West Virginia, United States, 26507
        • Recruiting
        • West Virginia University - Morgantown
        • Contact:
    • Wisconsin
      • Madison, Wisconsin, United States, 53792

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.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute Change in FEV1 % Predicted at Week 4 in Aminoglycoside (AG) Study
Time Frame: Four weeks
Difference between aminoglycoside (AG) study intervention arms (AG - Non-AG) in the absolute change in FEV1 % predicted from Week 0 (Day 0) to Week 4 (Day 28 ± 2 days)
Four weeks
Incidence of Adverse Events (AEs) in Aminoglycoside (AG) Study Intervention Arms
Time Frame: Six Weeks
Difference between aminoglycoside (AG) study intervention arms (AG - Non-AG) in the proportion of participants with at least one AE from Week 0 (Day 0) to Week 6 (Day 44 ± 2 days).
Six Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute Change in CFRSD-CRISS Score at Week 4 in Aminoglycoside (AG) Study
Time Frame: Four weeks
Difference between aminoglycoside (AG) study intervention arms (AG - Non-AG) in the absolute change in respiratory symptoms, as measured by the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Score (CFRSD-CRISS) from Week 0 (Day 0) to Week 4 (Day 28 ± 2 days). The CFRSD-CRISS is derived from a set of questions asking a participant to state the extent of their 8 respiratory symptoms: difficulty breathing, feverishness, tiredness, chills or sweats, coughing, coughing up mucus, tightness in the chest and wheezing. Each respiratory symptom is assigned a score from 0-4 based on the response, with zero corresponding to the absence of the symptom and four corresponding to symptom being present 'a great deal' or 'extremely'. A summed score (range from 0-24) is calculated for each participant and converted to a final score with a range of 0 to 100, where the lowest scores indicate improvement of symptoms.
Four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chris Goss

Collaborators

Medical University of South Carolina
University of Washington
Cystic Fibrosis Foundation

Investigators

  • Principal Investigator: Patrick Flume, MD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2023

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

November 15, 2026

Study Registration Dates

First Submitted

September 16, 2022

First Submitted That Met QC Criteria

September 16, 2022

First Posted (Actual)

September 21, 2022

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STOP360-IP-22 AG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cystic Fibrosis

Clinical Trials on Beta-lactam antibiotic

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe