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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2017-02-18

Brief Summary

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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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Detailed Description

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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.

Conditions

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Acute Bacterial Sinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

cefdinir

Group Type ACTIVE_COMPARATOR

Cefdinir (drug)

Intervention Type DRUG

cefdinir 300mg per orally twice daily for 10 days

2

amoxicillin/clavulanate

Group Type ACTIVE_COMPARATOR

amoxicillin/clavulanate

Intervention Type DRUG

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

Interventions

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Cefdinir (drug)

cefdinir 300mg per orally twice daily for 10 days

Intervention Type DRUG

amoxicillin/clavulanate

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No