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

Primary Purpose

Acute Bacterial Sinusitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cefdinir (drug)
amoxicillin/clavulanate
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Bacterial Sinusitis focused on measuring Acute bacterial sinusitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

cefdinir

amoxicillin/clavulanate

Outcomes

Primary Outcome Measures

Improvement in quality of life
SNOT 20 questionnaire

Secondary Outcome Measures

Clinical signs and symptoms alleviated

Full Information

First Posted
September 2, 2005
Last Updated
May 1, 2017
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT00147914
Brief Title
Comparison Study Between Cefdinir & Amoxicilline/Clavulanate in Acute Sinusitis and Assessment of 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 Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bacterial Sinusitis
Keywords
Acute bacterial sinusitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
cefdinir
Arm Title
2
Arm Type
Active Comparator
Arm Description
amoxicillin/clavulanate
Intervention Type
Drug
Intervention Name(s)
Cefdinir (drug)
Intervention Description
cefdinir 300mg per orally twice daily for 10 days
Intervention Type
Drug
Intervention Name(s)
amoxicillin/clavulanate
Intervention Description
1000mg /62.5mg extended release per orally twice daily for 10 days
Primary Outcome Measure Information:
Title
Improvement in quality of life
Time Frame
At baseline and within 1 week of completing treatment
Title
SNOT 20 questionnaire
Time Frame
At baseline and within 1 week of completing treatment
Secondary Outcome Measure Information:
Title
Clinical signs and symptoms alleviated
Time Frame
At baseline and within 1 week of completing treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacquelynne Corey, M.D.
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12422969
Citation
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.
Results Reference
background
PubMed Identifier
9129756
Citation
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. doi: 10.2500/105065897782537133.
Results Reference
background

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

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