Status:
COMPLETED
Comparison Study Between Cefdinir & Amoxicilline/Clavulanate in Acute Sinusitis and Assessment of Quality of Life
Lead Sponsor:
University of Chicago
Conditions:
Acute Bacterial Sinusitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 tw...
Detailed Description
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 Amox...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2017
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00147914
Start Date
February 1 2005
End Date
February 18 2017
Last Update
May 2 2017
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637