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...
Date First Received: September 2, 2005
Last Updated: March 12, 2007
Verified by: University of Chicago, March 2007
Clinical Trial Phase: Phase 4 | Start Date: February 2005
Overall Status: Active, not recruiting
Estimated Enrollment: 100
Brief Summary
Official Title: “A Comparison Study Between Cefdinir and Amoxicilline/Clavulanate in Patients With Acute Sinusitis and Assessment of Quality of Life (QOL)”
Condition Keyword(s):
Intervention(s):
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, Dose Comparison, Parallel Assignment, Efficacy Study
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Amoxicillin/Clavulanate (drug), Cefdinir (drug)
Outcome Measures for this Clinical Trial
Primary Measures
- Improvement in quality of life
- SNOT 20 questionnaire
Secondary Measures
- Clinical signs and symptoms alleviated
Criteria for Participation in this Clinical Trial
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
Clinical Trial Sponsor Information
Lead Sponsor: University of Chicago
Overall Clinical Trial Officials and Contacts
Jacquelynne Corey, M.D. Principal Investigator University of Chicago
Related Publications
References
Tantilipikorn P, Fritz M, Tanabodee J, Lanza DC, Kennedy DW. A comparison of endoscopic culture techniques for chronic rhinosinusitis. Am J Rhinol. 2002 Sep-Oct;16(5):255-60.
Vaidya AM, Chow JM, Stankiewicz JA, Young MR, Mathews HL. Correlation of middle meatal and maxillary sinus cultures in acute maxillary sinusitis. Am J Rhinol. 1997 Mar-Apr;11(2):139-43.
Additional Information
Information obtained from ClinicalTrials.gov on November 19, 2008
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
Clinical Trials Authorship and Review
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