Acute Bacterial Sinusitis (ABS) Clinical Trial
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
| NCT number | NCT00644553 |
| Other study ID # | M02-524 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | March 22, 2008 |
| Last updated | March 26, 2008 |
| Start date | May 2003 |
| Verified date | March 2008 |
| Source | Abbott |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 437 |
| Est. completion date | |
| Est. primary completion date | March 2004 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Abbott |
United States, Canada, Greece, Hungary, Italy, Lithuania, Poland, Romania, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical Response | 33 days | No | |
| Secondary | Radiographic Response | 33 days | No |