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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00644553
• Date of registration: 22/03/2008
• Prospective Registration: No
• Primary sponsor: Abbott
• Public title: Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis
• Scientific 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
• Date of first enrolment: May 2003
• Target sample size: 437
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00644553
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Canada, Greece, Hungary, Italy, Lithuania, Poland, Romania, Spain, United States

Key inclusion & exclusion criteria

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.



Age minimum: 12 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Acute Bacterial Sinusitis (ABS)

Intervention(s)

Drug: Amoxicillin

Drug: Clarithromycin

Primary Outcome(s)

Clinical Response [Time Frame: 33 days]

Secondary Outcome(s)

Radiographic Response [Time Frame: 33 days]

Secondary ID(s)

M02-524

Source(s) of Monetary Support

Please refer to primary and secondary sponsors