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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Acute Bacterial Sinusitis

Intervention / Treatment
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* Drug: Cefdinir (drug)
* Drug: amoxicillin/clavulanate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>cefdinir | Drug: Cefdinir (drug)<br>* cefdinir 300mg per orally twice daily for 10 days<br>|
| Active Comparator: 2<br>amoxicillin/clavulanate | Drug: amoxicillin/clavulanate<br>* 1000mg /62.5mg extended release per orally twice daily for 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in quality of life |  | At baseline and within 1 week of completing treatment | 
| SNOT 20 questionnaire |  | At baseline and within 1 week of completing treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical signs and symptoms alleviated |  | At baseline and within 1 week of completing treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute bacterial sinusitis