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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00643409 |
The objectives of the study were to confirm that a single, 2.0-g dose of azithromycin sustained release (SR) was at least as effective to 10 days of oral levofloxacin 500 mg once a day, when used to treat adults with uncomplicated, acute bacterial sinus infections, and to evaluate the safety of both treatments.
Condition | Intervention | Phase |
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Maxillary Sinusitis |
Drug: azithromycin SR (Zithromax; compound: CP-62,993) Other: placebo Drug: levofloxacin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Levofloxacin for the Treatment of Acute Bacterial Maxillary Sinusitis in Adults Undergoing Diagnostic Sinus Aspiration |
Enrollment: | 504 |
Study Start Date: | January 2003 |
Study Completion Date: | February 2004 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: azithromycin SR (Zithromax; compound: CP-62,993)
Azithromycin SR 2.0 g by mouth in the form of a slurry x 1 dose
Other: placebo
placebo
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2: Experimental |
Drug: levofloxacin
levofloxacin 500 mg capsule by mouth qd x 10 days
Other: placebo
placebo
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients were included if they had a clinical diagnosis of acute bacterial maxillary sinusitis as demonstrated by presence of the cardinal signs and symptoms for a minimum duration of 7 days, a sinus X-ray (Water's view) confirming the clinical diagnosis of maxillary sinusitus, and 2 or more of following: fever, leukocytosis, frequent coughing, headache, nasal congestion, or post-nasal drainage.
Exclusion Criteria:
Patients were excluded if they were treated with any systemic antibiotic within 7 days prior to enrollment, had symptoms lasting for longer than 28 days, had 4 or more episodes of acute sinusitis within the preceding 12 months, had nasal or sinus surgery within 3 months prior (except for a diagnostic procedure), or complicated or nosocomial sinusitis.
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A0661078 |
Study First Received: | March 19, 2008 |
Last Updated: | March 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00643409 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anti-Bacterial Agents Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases Azithromycin |
Ofloxacin Maxillary Sinusitis Anti-Infective Agents, Urinary Sinusitis |
Anti-Infective Agents Otorhinolaryngologic Diseases Molecular Mechanisms of Pharmacological Action Paranasal Sinus Diseases Ofloxacin Maxillary Sinusitis Anti-Infective Agents, Urinary Enzyme Inhibitors Sinusitis |
Renal Agents Nose Diseases Pharmacologic Actions Anti-Bacterial Agents Respiratory Tract Diseases Respiratory Tract Infections Azithromycin Therapeutic Uses Nucleic Acid Synthesis Inhibitors |