Official Title: “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”

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).

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Investigator), Parallel Assignment

Study Primary Completion Date: March 2004

Intervention(s) in this Clinical Trial

• Drug: Clarithromycin
  • Clarithromycin Extended-Release 500 mg tablet (2 tablets QD)
• Drug: Amoxicillin
  • Amoxicillin-clavulanate 875/125 mg tablet (1 tablet BID)

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
• Active Comparator: B

Primary Measures

• Clinical Response
  • Time Frame: 33 days
    Safety Issue?: No

Secondary Measures

• Radiographic Response
  • Time Frame: 33 days
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Abbott

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00644553

Study ID Number: M02-524

ClinicalTrials.gov Identifier: NCT00644553

Health Authority: United States: Food and Drug Administration