Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6+
SponsorChris Goss

About this trial

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?

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Beta-lactam antibiotic
  • Aminoglycoside

Treatment groups

730 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Chris Goss

Lead sponsor

Seattle Children's Hospital

Sponsor institution

University of Washington

Collaborator

Medical University of South Carolina

Collaborator

Cystic Fibrosis Foundation

Collaborator