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
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.
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
Improvement in quality of life
SNOT 20 questionnaire
Secondary outcome: Clinical signs and symptoms alleviated
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
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- 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
- 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
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