Comparison Study Between Cefdinir & Amoxicilline/Clavulanate in Acute Sinusitis and Assessment of Quality of Life

• Status: Completed
• Trial end date: 2017-02-18
• Target enrollment: 0
• Participant gender: All

Summary

This study is a comparison between two commonly used antibiotics (Cefdinir vs. Amoxicillin/Clavulanate) in patients with acute sinus infection, surveying quality of life. The hypothesis is that the two treatments would be at the least equivalent based on clinical outcome measures of improvement in quality of life.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Cefdinir; Cephalosporins; Clavulanic Acid; Clavulanic Acids

Criteria

Inclusion Criteria:

• Male and female outpatient adults greater than 18 years old fulfilling the case definition for acute bacterial sinusitis

• Case definition includes clinical signs and symptoms, radiographic findings and collection of purulent material from the sinus

Exclusion Criteria:

• Symptoms less than 7 days and more than 3 weeks

• History of sinus surgery within 3 months

• History of frequent sinus infections (more than 2 episodes within the last 6 months)

• History of kidney and liver disease

• Pregnant and nursing women

• Pre-existing disease that could predispose to sinus infections (cystic fibrosis or nasal polyps

• Immunosuppressed patients

• History of allergy to either drug. Patients with a documented history of allergies to either penicillin or cephalosporins will be excluded.