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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

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ClinicalTrials.gov Identifier: NCT00644553
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : March 27, 2008
Sponsor:
Information provided by:
Abbott

Brief Summary:
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 or disease Intervention/treatment Phase
Acute Bacterial Sinusitis (ABS) Drug: Clarithromycin Drug: Amoxicillin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 437 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : May 2003
Actual Primary Completion Date : March 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

Arm Intervention/treatment
Active Comparator: A Drug: Clarithromycin
Clarithromycin Extended-Release 500 mg tablet (2 tablets QD)
Other Names:
  • ABT-268
  • Biaxin

Active Comparator: B Drug: Amoxicillin
Amoxicillin-clavulanate 875/125 mg tablet (1 tablet BID)
Other Name: amoxicillin-clavulanate




Primary Outcome Measures :
  1. Clinical Response [ Time Frame: 33 days ]

Secondary Outcome Measures :
  1. Radiographic Response [ Time Frame: 33 days ]


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644553


  Show 53 Study Locations
Sponsors and Collaborators
Abbott

Responsible Party: Angela M Nilius, PhD, Abbott
ClinicalTrials.gov Identifier: NCT00644553     History of Changes
Other Study ID Numbers: M02-524
First Posted: March 27, 2008    Key Record Dates
Last Update Posted: March 27, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Amoxicillin
Clarithromycin
Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
beta-Lactamase Inhibitors