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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.
First Received: March 22, 2008   Last Updated: March 26, 2008   History of Changes
Sponsored by: Abbott
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00644553
  Purpose

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 III

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


Resource links provided by NLM:


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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644553

  Show 53 Study Locations
Sponsors and Collaborators
Abbott
  More Information

No publications provided

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

Study placed in the following topic categories:
Anti-Infective Agents
Anti-Bacterial Agents
Clarithromycin
Amoxicillin
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Clavulanic Acid
Clavulanic Acids
Sinusitis
Amoxicillin-Potassium Clavulanate Combination

Additional relevant MeSH terms:
Anti-Infective Agents
Amoxicillin
Otorhinolaryngologic Diseases
Molecular Mechanisms of Pharmacological Action
Paranasal Sinus Diseases
Clavulanic Acids
Enzyme Inhibitors
Sinusitis
Amoxicillin-Potassium Clavulanate Combination
Pharmacologic Actions
Nose Diseases
Protein Synthesis Inhibitors
Clarithromycin
Anti-Bacterial Agents
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Clavulanic Acid

ClinicalTrials.gov processed this record on September 10, 2009