Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Abbott
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
Treatment with any other investigational drug within 4 weeks prior to study drug administration.
Clareo Health | Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis
