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

CompletadoFase 3ClinicalTrials.gov

ID: NCT00643409Tipo: INTERVENTIONALInicio: 1 de ene de 2003Fin estimado: 1 de feb de 2004

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

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

drug

levofloxacin

levofloxacin 500 mg capsule by mouth qd x 10 days

other

placebo

Ubicaciones

Pfizer Investigational Site

Buenos Aires, Argentina

Patrocinadores

PrincipalPfizer

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