At a glance
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Randomized Clinical Trial to Evaluate Guidelines for Acute Rhinosinusitis (Phase IV Study)
In Brief
A Phase 4 clinical trial evaluating Acetaminophen, Amoxicillin, and 4 other interventions for Acute Respiratory Infections and Acute Rhinosinusitis. Completed, enrolled 172 participants across 1 site.
Detailed Summary
This study will compare the symptom relief provided by 5 cold medicines versus the symptom relief provided by the same 5 cold medicines plus the antibiotic, amoxicillin, in people who have sinus infections. Treatment with amoxicillin may be more effective than treatment with cold medicines alone. Two hundred adult volunteers, aged 18 to 70 years old, with sinus infections will participate in this study for 28 days. Volunteers will receive a 10-day course of either amoxicillin or placebo (substance containing no medication). In addition, all volunteers will receive pain medication, a chest decongestant, nasal decongestants, and cough medicine as needed. Volunteers will be interviewed by telephone on days 0, 3, 7, 10, and 28 following the start of treatment. The study will look at quality of life factors such as change in functional status (ability to perform daily activities) and symptoms, recurrence of the infection, satisfaction with care, and the direct costs of treatment.
Study Details
Timeline
Interventions
Symptomatic treatment: Dose: 500mg every 4 to 6 hours for pain or fever
Intervention drug: Dose: 500mg tid for 10 days
Symptomatic treatment: Dose: 10mls every 4 to 6 hours for cough
Symptomatic treatment: Dose: 600mg every 12 hours to thin secretions
Symptomatic treatment: Dose: 120mg every 12 hours for nasal congestion
Symptomatic treatment: Dose: 2 squeezes per nostril as needed for nasal congestion