Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis

Study Overview
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Brief Summary
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To compare the safety/tolerability and efficacy of a 14-day course of clarithromycin extended-release tablets (2 x 500 mg QD) with that of a 14-day course of amoxicillin-clavulanate tablets (875/125 mg BID) for the treatment of ambulatory subjects with Acute Bacterial Sinusitis (ABS).

Official Title
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A Phase IIIB/IV Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets vs. Amoxicillin-Clavulanate for the Treatment of Subjects With Acute Bacterial Sinusitis

Conditions
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Acute Bacterial Sinusitis (ABS)

Intervention / Treatment
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* Drug: Clarithromycin
* Drug: Amoxicillin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The female must be non-lactating and at no risk for pregnancy. Subject must have a diagnosis of ABS. The diagnosis must be based on the following: A sinus radiograph (Water's view) or CT scan with evidence of maxillary opacification or Air/fluid levels purulent discharge from the nose At least two of the following additional signs and symptoms lasting longer than seven days prior to and no longer than 28 days before Evaluation 1. A pre-treatment sample from a sinus puncture or Middle meatus endoscopy must be obtained for bacterial aerobic culture Susceptibility testing (applicable only for selected investigative sites). Subject must be a suitable candidate for oral antibiotic therapy and able to swallow tablets intact. Exclusion Criteria: A medical history of hypersensitivity or allergic reactions to clarithromycin, erythromycin, amoxicillin/clavulanate, any penicillin or any of the macrolide antibiotics. History of amoxicillin-clavulanate associated cholestatic jaundicehepatic dysfunction. Females who are pregnant or lactating. Subject has either of the following: Chronic sinusitis (signs and symptoms lasting longer than 28 days immediately prior to Evaluation 1) Significant anatomical abnormalities of the sinuses any other infection or Condition which necessitates use of a concomitant systemic antibiotic. Evidence of uncontrolled clinically significant cardiovascular, pulmonary, metabolic, gastrointestinal, neurological, psychiatric or endocrine disease, malignancy, or other abnormality (other than the disease being studied). Any underlying condition/disease, that would be likely to interfere with the completion of the course of study drug therapy or follow-up. Known significant renal or hepatic impairment (or disease). Subject who has taken: a systemic antibiotic within 2 weeks before study drug administration or a long-acting injectable antibiotic (e.g., penicillin G benzathine) within 4 weeks before study drug administration. Immunocompromised subjects (e.g., neutropenic subjects). Subjects with known HIV infection. Treatment with any other investigational drug within 4 weeks prior to study drug administration.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: Clarithromycin<br>* Clarithromycin Extended-Release 500 mg tablet (2 tablets QD)<br>* Other names: Biaxin;|
| Active Comparator: B<br> | Drug: Amoxicillin<br>* Amoxicillin-clavulanate 875/125 mg tablet (1 tablet BID)<br>* Other names: amoxicillin-clavulanate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response |  | 33 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Response |  | 33 days |