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

This study has been completed.
Information provided by:
Abbott Identifier:
First received: March 22, 2008
Last updated: March 26, 2008
Last verified: March 2008

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).

Condition Intervention Phase
Acute Bacterial Sinusitis (ABS)
Drug: Clarithromycin
Drug: Amoxicillin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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

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Further study details as provided by Abbott:

Primary Outcome Measures:
  • Clinical Response [ Time Frame: 33 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Radiographic Response [ Time Frame: 33 days ] [ Designated as safety issue: No ]

Enrollment: 437
Study Start Date: May 2003
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: Clarithromycin
Clarithromycin Extended-Release 500 mg tablet (2 tablets QD)
Other Names:
  • ABT-268
  • Biaxin
  • clarithromycin
Active Comparator: B Drug: Amoxicillin
Amoxicillin-clavulanate 875/125 mg tablet (1 tablet BID)
Other Name: amoxicillin-clavulanate


Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00644553

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Responsible Party: Angela M Nilius, PhD, Abbott Identifier: NCT00644553     History of Changes
Other Study ID Numbers: M02-524
Study First Received: March 22, 2008
Last Updated: March 26, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acids
Clavulanic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors processed this record on April 17, 2014