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Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study

Study acronym: STOP360AG
StatusRecruiting
PhasePhase 4
SponsorChris Goss
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary and study completion dates: Nov 15, 2026 to May 31, 2027v6
  2. Minor Study sites: 61 to 60v5
  3. Minor Site details revised at 25 of 61 sitesv4
  4. Minor Study sites: 57 to 61v3
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 57
    • Start date changed from estimate of Feb 1, 2023 to Apr 23, 2023
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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?
Trial Details
NCT Number NCT05548283
Lead Sponsor Chris Goss
Collaborators: University of Washington, Medical University of South Carolina, Cystic Fibrosis Foundation
Conditions
(from sponsor)
Cystic Fibrosis, Cystic Fibrosis Pulmonary Exacerbation
Related terms Cystic Fibrosis
Enrollment 730 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov