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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00147914
First received: September 2, 2005
Last updated: May 29, 2014
Last verified: May 2014
  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 4

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:


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 2014
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
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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:
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00147914     History of Changes
Other Study ID Numbers: 11791A
Study First Received: September 2, 2005
Last Updated: May 29, 2014
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
Clavulanic Acids
Clavulanic Acid
Amoxicillin-Potassium Clavulanate Combination
Cefdinir
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014