Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis
Information source: Abbott
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Bacterial Sinusitis (ABS)
Intervention: Clarithromycin (Drug); Amoxicillin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Abbott
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).
Clinical Details
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 design: Treatment, Randomized, Single Blind (Investigator), Parallel Assignment
Primary outcome: Clinical Response
Secondary outcome: Radiographic Response
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Thessaloniki 56430, Greece
Patra 26500, Greece
Athens 11522, Greece
Athens 115 27, Greece
Piraeus 18454, Greece
Thessaloniki 54636, Greece
Veszprem H-8200, Hungary
Salgotarjan H-3100, Hungary
Szombathely H-9700, Hungary
Budapest H-1096, Hungary
Budapest H-1062, Hungary
Budapest H-1097, Hungary
Budapest H-1106, Hungary
Palermo 90127, Italy
Pavia 27100, Italy
Genova 16132, Italy
Catania 95124, Italy
Padova 35128, Italy
Vilnius LT-2021, Lithuania
Vilnius LT-2014, Lithuania
Kaunas LT-3007, Lithuania
Vilnius LT-2025, Lithuania
Bydgoszcz 85-090, Poland
Bialystok 15-276, Poland
Lublin 20-954, Poland
Gliwice 44-100, Poland
Jelenia Gora 58-506, Poland
Wroclaw 51-124, Poland
Wroclaw 50-368, Poland
Bielsko-Biala 43-300, Poland
Bucharest 762631, Romania
Bucharest 773511, Romania
Barcelona 08036, Spain
Madrid 28805, Spain
Valladolid 47002, Spain
Badajoz 06010, Spain
Palma de Mallorca 07014, Spain
Birmingham, Alabama 35235, United States
Phoenix, Arizona 85014, United States
La Jolla, California 92037, United States
San Luis Obispo, California 93405, United States
Clovis, California 93611, United States
Coeur d'Alene, Idaho 83814, United States
Charlotte, North Carolina 28210, United States
Columbus, Ohio 43235, United States
Toronto, Ontario M9W 4L6, Canada
Kitchener, Ontario N2C 2N9, Canada
Eugene, Oregon 97404, United States
Sherbrooke, Quebec J1J 2B8, Canada
Saskatoon, Saskatchewan S7H 0W6, Canada
Johnson City, Tennessee 37601, United States
San Antonio, Texas 78209, United States
Spokane, Washington 99216, United States
Additional Information
Starting date: May 2003
Last updated: March 26, 2008
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