This trial is active, not recruiting.

Condition acute bacterial sinusitis
Treatments cefdinir (drug), amoxicillin/clavulanate
Phase phase 4
Sponsor University of Chicago
Start date February 2005
End date February 2007
Trial size 100 participants
Trial identifier NCT00147914, 11791A


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
(Active Comparator)
cefdinir (drug)
cefdinir 300mg per orally twice daily for 10 days
(Active Comparator)
1000mg /62.5mg extended release per orally twice daily for 10 days

Primary Outcomes

Improvement in quality of life
time frame: At baseline and within 1 week of completing treatment
SNOT 20 questionnaire
time frame: At baseline and within 1 week of completing treatment

Secondary Outcomes

Clinical signs and symptoms alleviated
time frame: At baseline and within 1 week of completing treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Comparison Study Between Cefdinir and Amoxicilline/Clavulanate in Patients With Acute Sinusitis and Assessment of Quality of Life (QOL)
Principal investigator Jacquelynne Corey, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Chicago.