Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis

Abbott

Status and phase

Completed

Phase 3

Conditions

Acute Bacterial Sinusitis (ABS)

Treatments

Drug: Amoxicillin

Drug: Clarithromycin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00644553

M02-524

Details and patient eligibility

About

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).

Enrollment

437 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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.