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Completed

NCT Number: NCT00147914

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

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.

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Key information

Conditions

Acute Bacterial Sinusitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cefdinir (drug)

Drug

cefdinir 300mg per orally twice daily for 10 days

Amoxicillin/clavulanate

Drug

1000mg /62.5mg extended release per orally twice daily for 10 days

Primary outcomes

  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 outcomes

  1. Clinical signs and symptoms alleviated

    Time frame: At baseline and within 1 week of completing treatment

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2017
First posted
Sep 7, 2005
Registry last updated
May 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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