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

May 1, 2017 updated by: University of Chicago

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in quality of life
Time Frame: At baseline and within 1 week of completing treatment
At baseline and within 1 week of completing treatment
SNOT 20 questionnaire
Time Frame: At baseline and within 1 week of completing treatment
At baseline and within 1 week of completing treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical signs and symptoms alleviated
Time Frame: At baseline and within 1 week of completing treatment
At baseline and within 1 week of completing treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

February 18, 2017

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 7, 2005

Study Record Updates

Last Update Posted (Actual)

May 2, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11791A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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