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A Comparison Study Between Cefdinir and Amoxicilline/Clavulonate in Patients with Acute Sinusitis and Assessment of Quality of Life - Article


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Sinusitis

Acute sinusitis; Chronic sinusitis

Clinical Trial: A Comparison Study Between Cefdinir and Amoxicilline/Clavulonate in Patients with Acute Sinusitis and Assessment of Quality of Life

This study is currently recruiting patients.
Verified by University of Chicago September 2005

Sponsored by: University of Chicago
Information provided by: University of Chicago
ClinicalTrials.gov Identifier: NCT00147914

Purpose

Comparison between two comonly used antibiotics (Cefdinir vs. Amoxicillin/Clavulonate)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.
Condition Intervention Phase
Acute bacterial sinusitis
  Drug: Amoxicillin/Clavulonate (drug), Cefdinir (drug)
 Phase IV

MedlinePlus related topics:  Sinusitis;   Skin Conditions

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study

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

Further Study Details: 
Primary Outcomes: Improvement in quality of life; SNOT 20 questionnaire
Secondary Outcomes: Clinical signs and symptoms alleviated
Expected Total Enrollment:  100

Study start: February 2005
Last follow-up: December 2005

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/Clavulonate 1000 mg/62.5 mg XR BID, in the treatment of acute bacterial sinusitis.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

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.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00147914

Patricia M. Fishman, M.D.      773-702-8205    pfishman@surgery.bsd.uchicago.edu
Jacquelynne P. Corey, M.D.      773-702-0382    jcorey@surgery.bsd.uchicago.edu

Illinois
      University of Chicago, Chicago,  Illinois,  60637,  United States; Recruiting
Jacquelynne P. Corey, M.D.  773-702-0382 

Study chairs or principal investigators

Jacquelynne Corey, M.D.,  Principal Investigator,  University of Chicago   

More Information

Publications

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.

Study ID Numbers:  11791A
Last Updated:  September 6, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00147914
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13


Source: ClinicalTrials.gov
Cache Date: September 14, 2005


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Page Updated: December 9, 2005
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