At a glance
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OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis: The OPTIMIZE Multicenter, Placebo-Controlled, Double-Blind, Randomized Trial
In Brief
A Phase 3 clinical trial evaluating azithromycin, placebo, and 1 other intervention for Cystic Fibrosis. Completed, enrolled 221 participants across 45 sites.
Detailed Summary
The purpose of this trial is to compare the effects of treatment with tobramycin solution for inhalation (TIS) with and without azithromycin in people with cystic fibrosis (CF) age 6 months to 18 years who have early isolation of Pseudomonas aeruginosa (Pa) from a respiratory culture. Specimens of blood and sputum or throat swabs will be taken during the study along with pulmonary function testing. Participants will receive initial treatment with TIS followed additional treatment with TIS if quarterly respiratory cultures are positive for Pa in addition to either azithromycin or placebo for 18 months.
Study Details
Timeline
Interventions
3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months
3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months
300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months