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

Acute Bacterial Sinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00147914
• Other study ID #: 11791A
• Status: Completed
• Phase: Phase 4
• First received: September 2, 2005
• Last updated: May 1, 2017
• Start date: February 2005
• Est. completion date: February 18, 2017

Study information

• Verified date: May 2017
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 18, 2017
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Bacterial Sinusitis
• Sinusitis

Intervention

Drug:
• Cefdinir (drug)
cefdinir 300mg per orally twice daily for 10 days
• amoxicillin/clavulanate
1000mg /62.5mg extended release per orally twice daily for 10 days

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in quality of life		At baseline and within 1 week of completing treatment
Primary	SNOT 20 questionnaire		At baseline and within 1 week of completing treatment
Secondary	Clinical signs and symptoms alleviated		At baseline and within 1 week of completing treatment