At a glance
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Standardized Treatment of Pulmonary Exacerbations II (STOP2)
In Brief
A Phase 4 clinical trial evaluating Standard of care IV antibiotic(s) for Pulmonary Cystic Fibrosis. Completed, enrolled 982 participants across 58 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.