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

Information source: University of Chicago
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Bacterial Sinusitis

Intervention: Amoxicillin/Clavulanate (drug), Cefdinir (drug) (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: University of Chicago

Official(s) and/or principal investigator(s):
Jacquelynne Corey, M.D., Principal Investigator, Affiliation: University of Chicago

Summary

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.

Clinical Details

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

Study design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study

Primary outcome:

Improvement in quality of life

SNOT 20 questionnaire

Secondary outcome: Clinical signs and symptoms alleviated

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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.

Locations and Contacts

University of Chicago, Chicago, Illinois 60637, United States
Additional Information

Related 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.

Starting date: February 2005
Ending date: May 2006
Last updated: March 12, 2007

Page last updated: June 20, 2008

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