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

March 26, 2008 updated by: Abbott

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

437

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kitchener, Ontario, Canada, N2C 2N9
      • Toronto, Ontario, Canada, M9W 4L6
    • Quebec
      • Sherbrooke, Quebec, Canada, J1J 2B8
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7H 0W6
  • Greece
      • Athens, Greece, 115 27
      • Athens, Greece, 11522
      • Patra, Greece, 26500
      • Piraeus, Greece, 18454
      • Thessaloniki, Greece, 54636
      • Thessaloniki, Greece, 56430
  • Hungary
      • Budapest, Hungary, H-1106
      • Budapest, Hungary, H-1097
      • Budapest, Hungary, H-1096
      • Budapest, Hungary, H-1062
      • Salgotarjan, Hungary, H-3100
      • Szombathely, Hungary, H-9700
      • Veszprem, Hungary, H-8200
  • Italy
      • Catania, Italy, 95124
      • Genova, Italy, 16132
      • Padova, Italy, 35128
      • Palermo, Italy, 90127
      • Pavia, Italy, 27100
  • Lithuania
      • Kaunas, Lithuania, LT-3007
      • Vilnius, Lithuania, LT-2014
      • Vilnius, Lithuania, LT-2021
      • Vilnius, Lithuania, LT-2025
  • Poland
      • Bialystok, Poland, 15-276
      • Bielsko-Biala, Poland, 43-300
      • Bydgoszcz, Poland, 85-090
      • Gliwice, Poland, 44-100
      • Jelenia Gora, Poland, 58-506
      • Lublin, Poland, 20-954
      • Wroclaw, Poland, 51-124
      • Wroclaw, Poland, 50-368
  • Romania
      • Bucharest, Romania, 762631
      • Bucharest, Romania, 773511
  • Spain
      • Badajoz, Spain, 06010
      • Barcelona, Spain, 08036
      • Madrid, Spain, 28805
      • Palma de Mallorca, Spain, 07014
      • Valladolid, Spain, 47002
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
    • Arizona
      • Phoenix, Arizona, United States, 85014
    • California
      • Clovis, California, United States, 93611
      • La Jolla, California, United States, 92037
      • San Luis Obispo, California, United States, 93405
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
    • Ohio
      • Columbus, Ohio, United States, 43235
    • Oregon
      • Eugene, Oregon, United States, 97404
    • Tennessee
      • Johnson City, Tennessee, United States, 37601
    • Texas
      • San Antonio, Texas, United States, 78209
    • Washington
      • Spokane, Washington, United States, 99216

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: A
Drug: Clarithromycin
Clarithromycin Extended-Release 500 mg tablet (2 tablets QD)
Other Names:
  • Biaxin
  • ABT-268
ACTIVE_COMPARATOR: B
Drug: Amoxicillin
Amoxicillin-clavulanate 875/125 mg tablet (1 tablet BID)
Other Names:
  • amoxicillin-clavulanate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical Response
Time Frame: 33 days
33 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Radiographic Response
Time Frame: 33 days
33 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (ACTUAL)

March 1, 2004

Study Registration Dates

First Submitted

March 22, 2008

First Submitted That Met QC Criteria

March 26, 2008

First Posted (ESTIMATE)

March 27, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 27, 2008

Last Update Submitted That Met QC Criteria

March 26, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M02-524

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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