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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2009 by University of Chicago. Recruitment status was Active, not recruiting

First Received on September 2, 2005. Last Updated on March 24, 2009 History of Changes

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

Purpose

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.

Condition	Intervention	Phase
Acute Bacterial Sinusitis	Drug: Cefdinir (drug) Drug: amoxicillin/clavulanate	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Comparison Study Between Cefdinir and Amoxicilline/Clavulanate in Patients With Acute Sinusitis and Assessment of Quality of Life (QOL)

Resource links provided by NLM:

MedlinePlus related topics: Sinusitis

Drug Information available for: Amoxicillin Amoxicillin sodium Clavulanic acid Amoxicillin trihydrate Cefdinir

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:

Improvement in quality of life [ Time Frame: At baseline and within 1 week of completing treatment ] [ Designated as safety issue: No ]
SNOT 20 questionnaire [ Time Frame: At baseline and within 1 week of completing treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical signs and symptoms alleviated [ Time Frame: At baseline and within 1 week of completing treatment ] [ Designated as safety issue: No ]

Enrollment:	100
Study Start Date:	February 2005
Estimated Study Completion Date:	December 2009
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 cefdinir	Drug: Cefdinir (drug) cefdinir 300mg per orally twice daily for 10 days
Active Comparator: 2 amoxicillin/clavulanate	Drug: amoxicillin/clavulanate 1000mg /62.5mg extended release per orally twice daily for 10 days

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147914

Locations

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

Sponsors and Collaborators

University of Chicago

Investigators

Principal Investigator:

Jacquelynne Corey, M.D.

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.

Responsible Party:	Jacquelynne P. Corey, M.D., University of Chicago
ClinicalTrials.gov Identifier:	NCT00147914 History of Changes
Other Study ID Numbers:	11791A
Study First Received:	September 2, 2005
Last Updated:	March 24, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Chicago:

Acute bacterial sinusitis

Additional relevant MeSH terms:

Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acids

Clavulanic Acid
Cefdinir
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012