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

NCT00147914 | Completed Phase 4 DMC

• 1 other identifier: 11791A
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Bacterial Sinusitis

Keywords

Acute bacterial sinusitis

Outcome Measures

Primary Outcomes (2)

• Improvement in quality of life

  At baseline and within 1 week of completing treatment

• SNOT 20 questionnaire

  At baseline and within 1 week of completing treatment

Secondary Outcomes (1)

• Clinical signs and symptoms alleviated

  At baseline and within 1 week of completing treatment

Study Arms (2)

1

ACTIVE COMPARATOR

cefdinir

Drug: Cefdinir (drug)

2

ACTIVE COMPARATOR

amoxicillin/clavulanate

Drug: amoxicillin/clavulanate

Interventions

Cefdinir (drug) DRUG

cefdinir 300mg per orally twice daily for 10 days

1

amoxicillin/clavulanate DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related 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.

  PMID: 12422969 BACKGROUND

• 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. doi: 10.2500/105065897782537133.

  PMID: 9129756 BACKGROUND

MeSH Terms

Interventions

Cefdinir; Pharmaceutical Preparations; Amoxicillin-Potassium Clavulanate Combination

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Clavulanic Acid; Clavulanic Acids; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Drug Combinations

Study Officials

• Jacquelynne Corey, M.D.

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 7, 2005
• Study Start: February 1, 2005
• Primary Completion: February 1, 2007
• Study Completion: February 18, 2017
• Last Updated: May 2, 2017

Record last verified: 2017-05

Locations

US (1)