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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00147914

Enrollment

100

Registered

2005-09-07

Start date

2005-02-28

Completion date

2017-02-18

Last updated

2017-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Bacterial Sinusitis

Keywords

Acute bacterial sinusitis

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.

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.

Interventions

DRUGCefdinir (drug)

cefdinir 300mg per orally twice daily for 10 days

DRUGamoxicillin/clavulanate

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Clinical signs and symptoms alleviated	At baseline and within 1 week of completing treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026