Standardizing Treatments for Pulmonary Exacerbations: A platform for evaluating treatment decisions to improve outcomes (STOP360)
CF STOP360 Site
What is the goal of the study?
This prospective study will enroll patients with CF who are 6 years of age and older and being treated for a pulmonary exacerbation with intravenous antibiotics for 14 (+/- 2) days and meet eligibility criteria. Participants will be randomized to one of two treatment groups: IV beta-lactam only or IV beta-lactam and IV tobramycin. The aim of the study is to determine if participants in both groups have the same improvement in lung function and symptoms over the study period. There will be three study visits: Enrollment, Week 4 and phone call at Week 6. Safety monitoring will occur in accordance with institutional standards for treatment with these antibiotics, such as blood tests, audiograms if indicated, pulmonary function tests and these clinical data will be recorded for the study. Participants will complete symptom questionnaires electronically. Adverse events will be assessed and reported throughout the study.
Who can participate in the study?
Please contact the study team listed below to learn more.