Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis
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
1 other identifier
interventional
437
9 countries
53
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 22, 2008
CompletedFirst Posted
Study publicly available on registry
March 27, 2008
CompletedMarch 27, 2008
March 1, 2008
10 months
March 22, 2008
March 26, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical Response
33 days
Secondary Outcomes (1)
Radiographic Response
33 days
Study Arms (2)
A
ACTIVE COMPARATORB
ACTIVE COMPARATORInterventions
Clarithromycin Extended-Release 500 mg tablet (2 tablets QD)
Amoxicillin-clavulanate 875/125 mg tablet (1 tablet BID)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (53)
Unknown Facility
Birmingham, Alabama, 35235, United States
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Phoenix, Arizona, 85014, United States
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Clovis, California, 93611, United States
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La Jolla, California, 92037, United States
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San Luis Obispo, California, 93405, United States
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Coeur d'Alene, Idaho, 83814, United States
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Charlotte, North Carolina, 28210, United States
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Columbus, Ohio, 43235, United States
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Eugene, Oregon, 97404, United States
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Johnson City, Tennessee, 37601, United States
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San Antonio, Texas, 78209, United States
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Spokane, Washington, 99216, United States
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Kitchener, Ontario, N2C 2N9, Canada
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Toronto, Ontario, M9W 4L6, Canada
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Sherbrooke, Quebec, J1J 2B8, Canada
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Saskatoon, Saskatchewan, S7H 0W6, Canada
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Athens, 115 27, Greece
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Athens, 11522, Greece
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Pátrai, 26500, Greece
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Piraeus, 18454, Greece
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Thessaloniki, 54636, Greece
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Thessaloniki, 56430, Greece
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Budapest, H-1062, Hungary
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Budapest, H-1096, Hungary
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Budapest, H-1097, Hungary
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Budapest, H-1106, Hungary
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Salgótarján, H-3100, Hungary
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Szombathely, H-9700, Hungary
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Veszprém, H-8200, Hungary
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Catania, 95124, Italy
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Genova, 16132, Italy
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Padua, 35128, Italy
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Palermo, 90127, Italy
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Pavia, 27100, Italy
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Kaunas, LT-3007, Lithuania
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Vilnius, LT-2014, Lithuania
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Vilnius, LT-2021, Lithuania
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Vilnius, LT-2025, Lithuania
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Bialystok, 15-276, Poland
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Bielsko-Biala, 43-300, Poland
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Bydgoszcz, 85-090, Poland
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Gliwice, 44-100, Poland
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Jelenia Góra, 58-506, Poland
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Lublin, 20-954, Poland
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Wroclaw, 50-368, Poland
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Wroclaw, 51-124, Poland
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Bucharest, 762631, Romania
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Bucharest, 773511, Romania
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Badajoz, 06010, Spain
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Barcelona, 08036, Spain
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Madrid, 28805, Spain
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Palma de Mallorca, 07014, Spain
Unknown Facility
Valladolid, 47002, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 22, 2008
First Posted
March 27, 2008
Study Start
May 1, 2003
Primary Completion
March 1, 2004
Last Updated
March 27, 2008
Record last verified: 2008-03