Standardized Treatment of Pulmonary Exacerbations II
Status:
Completed
Trial end date:
2020-03-06
Target enrollment:
Participant gender:
Summary
Cystic fibrosis (CF), a life-shortening genetic disease, is marked by acute episodes during
which symptoms of lung infection increase and lung function decreases. These pulmonary
exacerbations are treated with varying antibiotics for varying time periods based on needs
determined by individual patients, their families, and the health care providers. Cystic
fibrosis pulmonary guidelines for the treatment of pulmonary exacerbation published by the
Cystic Fibrosis Foundation (CFF) in 2009 provided recommendations for treatment and also
identified key questions for which additional studies were needed.
A strong desire among clinicians to reduce treatment durations (and reduce cost,
inconvenience, and potential toxicities) is in conflict with belief that patients not
responding robustly to treatment might benefit from extending treatment.
This randomized, controlled, open-label study is designed to evaluate the efficacy and safety
of differing durations of IV treatment, given in the hospital or at home for a pulmonary
exacerbation in adult patients with CF.
Phase:
Phase 4
Details
Lead Sponsor:
Chris Goss
Collaborators:
CF Therapeutics Development Network Coordinating Center Cystic Fibrosis Foundation Cystic Fibrosis Foundation Therapeutics Medical University of South Carolina University of Washington