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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
Sponsor: 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

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

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 November 22, 2009