Status:
COMPLETED
Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis
Lead Sponsor:
Abbott
Conditions:
Acute Bacterial Sinusitis (ABS)
Eligibility:
All Genders
12+ years
Phase:
PHASE3
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 m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
437 Patients enrolled
Trial Details
Trial ID
NCT00644553
Start Date
May 1 2003
Last Update
March 27 2008
Active Locations (53)
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1
Birmingham, Alabama, United States, 35235
2
Phoenix, Arizona, United States, 85014
3
Clovis, California, United States, 93611
4
La Jolla, California, United States, 92037