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

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.