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

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ClinicalTrials.gov Identifier: NCT00147914
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acute Bacterial Sinusitis Drug: Cefdinir (drug) Drug: amoxicillin/clavulanate Phase 4

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  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
Study Start Date : February 2005
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 18, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Improvement in quality of life [ Time Frame: At baseline and within 1 week of completing treatment ]
  2. SNOT 20 questionnaire [ Time Frame: At baseline and within 1 week of completing treatment ]

Secondary Outcome Measures :
  1. Clinical signs and symptoms alleviated [ Time Frame: At baseline and within 1 week of completing treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00147914     History of Changes
Other Study ID Numbers: 11791A
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: May 2017

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 Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
Cefdinir
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action