Official Title: “A Comparison Study Between Cefdinir and Amoxicilline/Clavulanate in Patients With Acute Sinusitis and Assessment of Quality of Life (QOL)”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Efficacy Study

Study Primary Completion Date: February 2007

The purpose if this investigation is to evaluate the rate of improvement ub Quality of LIfe (QOL) in two different medications, a 10-day course of Cefdinir 300 mg PO BID versus a 10-day course of Amoxicillin/Clavulanate 1000 mg/62.5 mg XR BID, in the treatment of acute bacterial sinusitis.

Intervention(s) in this Clinical Trial

• Drug: Cefdinir (drug)
  • cefdinir 300mg per orally twice daily for 10 days
• Drug: amoxicillin/clavulanate
  • 1000mg /62.5mg extended release per orally twice daily for 10 days

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • cefdinir
• Active Comparator: 2
  • amoxicillin/clavulanate

Primary Measures

• Improvement in quality of life
  • Time Frame: At baseline and within 1 week of completing treatment
    Safety Issue?: No
• SNOT 20 questionnaire
  • Time Frame: At baseline and within 1 week of completing treatment
    Safety Issue?: No

Secondary Measures

• Clinical signs and symptoms alleviated
  • Time Frame: At baseline and within 1 week of completing treatment
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Chicago

Overall Clinical Trial Officials and Contacts

Jacquelynne Corey, M.D. Principal Investigator University of Chicago  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00147914

Study ID Number: 11791A

ClinicalTrials.gov Identifier: NCT00147914

Health Authority: United States: Institutional Review Board