STOP360 (STOP360AG)

Evaluating Antibiotic Treatments for Pulmonary Exacerbations in Cystic Fibrosis

Recruiting
6 years or above
All
Phase 4
730 participants needed
1 Location

Brief description of 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?

Detailed description of 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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cystic Fibrosis, Cystic Fibrosis Pulmonary Exacerbation
  • Age: 6 years or above
  • Gender: All

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

This study investigates pulmonary exacerbations in people with cystic fibrosis. The purpose of this study is to compare the effects of different antibiotic treatments given through a tube into a vein.

The study evaluates the effectiveness and safety of using one type of antibiotic versus two types in treating pulmonary exacerbations. It looks at how these treatments affect lung function and symptoms.

  • Who can participate: Participants must be 6 years or older with a documented diagnosis of cystic fibrosis and a clinician's intent to treat a CF exacerbation with a planned 14-day course of IV antimicrobials.
  • Study details: Participants will receive either one type of antibiotic or two different types through a vein. The study will measure changes in lung function over time.
  • Study timelines: The study will last 28 days.
Updated on 08 Jul 2026. Study ID: 22-1349

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