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



Status:Completed
Conditions:Sinusitis
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:18 - Any
Updated:5/3/2017
Start Date:February 2005
End Date:February 18, 2017

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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.

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.

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.
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5801 South Ellis Avenue
Chicago, Illinois 60637
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