Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study

Launched by CHRIS GOSS · Sep 16, 2022

Keywords

ClinConnect Summary

This clinical trial, called the Aminoglycoside Study, is focused on improving how we treat lung infections in people with cystic fibrosis (CF). Specifically, it looks at what happens when patients experiencing a worsening of their lung symptoms (known as a pulmonary exacerbation) receive different types of antibiotics through an IV (a tube inserted into a vein). The study aims to find out if using one type of antibiotic is just as effective as using two different types, which could help doctors make better treatment decisions for CF patients.

To join the study, participants must be at least 6 years old and have a confirmed diagnosis of cystic fibrosis. They also need to be starting a 14-day course of IV antibiotics due to a recent lung infection. There are some criteria that would exclude someone from participating, such as being pregnant or having certain health issues related to kidney function. If eligible, participants can expect to receive close medical supervision and have their lung health monitored throughout the study. This research is important as it could lead to better treatment options for those with cystic fibrosis.

Gender

ALL

Eligibility criteria

• 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