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

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.