Comparison Study Between Cefdinir & Amoxicilline/Clavulanate in Acute Sinusitis and Assessment of Quality of Life
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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 Amoxicillin/Clavulanate 1000 mg/62.5 mg XR BID, in the treatment of acute bacterial sinusitis.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
100 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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