AVELOX (moxifloxacin HCl) monotherapy at 400 mg once daily is as effective as the high-dose combination of levofloxacin (500 mg twice daily) plus ceftriaxone (2 g once daily) in treating patients with severe community-acquired pneumonia (CAP) requiring hospitalization, according to results of a new clinical study presented at the 16th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Nice, France.

Known as the MOTIV (Moxifloxacin Treatment Intravenous) study, the head-to-head comparison of once-daily AVELOX monotherapy to a combination of high-dose levofloxacin plus high-dose ceftriaxone showed no significant difference in clinical cure rates (4-14 days after the last dose), the primary efficacy endpoint for the two per protocol treatment groups (86.9 percent vs. 89.9 percent, respectively), including CAP patients with the most severe pneumonia.

The per protocol population consisted of 569 patients. A total of 748 patients were enrolled in the study, of which 738 patients were randomized. Both treatments were well tolerated in the study, with similar adverse event profiles.

"The results of the MOTIV study are important because community-acquired pneumonia is a particular concern for people with chronic illnesses or impaired immune systems, and is a common cause of hospitalization worldwide," said Antoni Torres, M.D., professor of pulmonology at the University of Barcelona in Spain.

"CAP can critically affect older patients who may be struggling with existing conditions such as heart disease and diabetes," he added. "These results provide additional evidence that AVELOX is a safe and effective treatment for patients with CAP."

CAP affects approximately 5.6 million adults in the United States each year, with elderly patients (age 65 and above) 60 percent more likely than the general population to develop the infection.1,2

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AVELOX, a broad-spectrum fluoroquinolone antibiotic, has been shown to be safe and effective as monotherapy in treating patients with CAP and is approved for this indication. (See About AVELOX section below for more information.)

References:

1.Centers for Disease Control and Prevention. Premature deaths, monthly mortality and monthly physician contacts: United States. MMWR 1997;46:556.
2.Stanton M. Research in Action, Issues 7: Improving Treatment Decisions for Patients with Community-Acquired Pneumonia. Available at ahrq/clinic/pneumonia/pneumonria.htm. Accessed on August 30, 2005.

Contact: Robert Consalvo
Schering-Plough Corporation

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