Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05548283

Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside 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?

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Pulmonary Exacerbation Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beta-lactam antibiotic

Drug

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

Aminoglycoside

Drug

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

Primary outcomes

  1. 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)

  2. 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).

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Barbra Fogarty

CONTACT

[email protected]

206-884-7592

Rachael Buckingham, BS

CONTACT

[email protected]

206-884-7517

Sponsors and collaborators

Lead sponsor

Chris Goss

Other

Collaborators

  • Cystic Fibrosis Foundation
  • Medical University of South Carolina
  • University of Washington

Registry information

Official study title

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

Acronym: STOP360AG

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 21, 2022
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.