A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Sinus Infections in Adults
NCT00643409
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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 sinusitis, and 2 or more of following: fever, leukocytosis, frequent coughing, headache, nasal congestion, or post-nasal drainage.
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.
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Descriptive Information | ||||
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Brief Title ICMJE | A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Sinus Infections in Adults | |||
Official Title ICMJE | 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 | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Maxillary Sinusitis | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 541 | |||
Original Actual Enrollment ICMJE | 504 | |||
Actual Study Completion Date ICMJE | February 2004 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | 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 sinusitis, 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. | |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Chile, Costa Rica, Czech Republic, Estonia, Germany, India, Lithuania, Mexico, Poland, Russian Federation, Slovakia, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00643409 | |||
Other Study ID Numbers ICMJE | A0661078 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | May 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |