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

Phase 4

Completed

• Conditions: Acute Bacterial Sinusitis
• Interventions: Drug: Cefdinir (drug); Drug: amoxicillin/clavulanate

• Registration Number: NCT00147914
• Lead Sponsor: University of Chicago

Brief 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.

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.

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-07
• Primary Completion: 2007-02
• Study Completion: 2017-02-18
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Cefdinir (drug)	cefdinir
2	amoxicillin/clavulanate	amoxicillin/clavulanate

Primary Outcome Measures

Name	Time	Method
Improvement in quality of life	At baseline and within 1 week of completing treatment
SNOT 20 questionnaire	At baseline and within 1 week of completing treatment

Secondary Outcome Measures

Name	Time	Method
Clinical signs and symptoms alleviated	At baseline and within 1 week of completing treatment

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States