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Volume 134, Issue 1, Pages 10-17 (January 2006)


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A Trial of High-Dose, Short-Course Levofloxacin for the Treatment of Acute Bacterial Sinusitis

These data have been presented in poster form at the 2005 Annual Meeting of the American Academy of Allergy, Asthma, and Immunology, San Antonio, TX, March 18-22, 2005.

Michael Poole, MD, PhDa, Jack Anon, MDb, Margaret Paglia, MHSA, BSNc, Jim Xiang, PhDc, Mohammed Khashab, MBAc, James Kahn, MDcCorresponding Author Informationemail address

Objective

Compare two dosage strengths of levofloxacin in the treatment of acute bacterial sinusitis.

Study design and setting

Multicenter clinical trial comparing levofloxacin 750 mg for 5 days vs levofloxacin 500 mg for 10 days.

Results

Sinus fluid samples were obtained by antral puncture (59.2%) or by sinus endoscopy (40.8%). Among microbiologically evaluable patients, 91.4% (139/152) of patients receiving levofloxacin 750 mg achieved clinical success vs 88.6% (132/149) of patients receiving levofloxacin 500 mg (95% CI −10.0, 4.2). Clinical success rates by pathogen were above 90% in both treatment groups for the 3 typical pathogens of acute sinusitis: Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. The safety profile of the 2 dosage strengths was similar.

Conclusion

Levofloxacin 750 mg for 5 days is noninferior to levofloxacin 500 mg for 10 days.

Significance

Levofloxacin 750 mg for 5 days represents a safe and effective treatment regimen for acute bacterial sinusitis.

EBM rating: A-1b

a Georgia Ear Institute, Savannah, Georgia

b University of Pittsburgh, Pittsburgh, Pennsylvania

c Ortho-McNeil Pharmaceutical, Raritan, Raritan, New Jersey

Corresponding Author InformationReprint requests: James Kahn, MD, Ortho-McNeil Pharmaceutical, 1000 Route 202, Raritan, NJ 08869

 This study was sponsored by Ortho-McNeil Pharmaceutical.

PII: S0194-5998(05)02147-9

doi:10.1016/j.otohns.2005.11.026


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