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Cethromycin achieves all endpoints in second pivotal Phase III Trial for treatment for pneumonia
Date:11/15/2007

or trials designed to assess the safety and effectiveness of cethromycin in CAP patients compared to Biaxin. Trial CL-06 enrolled patients from clinics in Europe, South America and Israel and Trial CL-05 enrolled patients from the United States, Canada and South Africa. In both trials, cethromycin was evaluated using a 300 mg once-daily oral dosing regimen compared to 250 mg twice-daily dosing for Biaxin, both over a seven-day course of therapy. Biaxin is an FDA-approved standard of care antibiotic currently indicated for the treatment of CAP.

The primary endpoint for both trials was the clinical cure rate at the test-of-cure visit (Day 14-21 post-initiation of dosing). The eligibility of patients for each trial was based on clinical signs and symptoms as well as chest X-ray results as evaluated by an independent radiologist. Extensive electrocardiogram and liver function test monitoring were incorporated into the study design in order to examine safety in these areas and add to the safety database established in previous cethromycin clinical trials.

Results of Trial CL-05

In Trial CL-05, cethromycin met all efficacy endpoints and demonstrated a favorable safety profile as outlined below:

  • Per protocol clinical cure rate (PPc)- cethromycin 94.0% (205/218) compared to Biaxin 93.8% (195/208) [-4.5, +5.1] (p>0.9999) PPc is defined as subjects who have completed the minimum required study medication, have confirmed clinical diagnosis of CAP supported by a positive chest X-ray and appropriate clinical signs/symptoms of CAP, and have had no other systemic antibacterial agents administered during or prior to the study period. Based on the 94.0% clinical cure rate for cethromycin being greater than 90%, a delta value of 10% or less on the lower bound and greater than zero on the upper bound [-4.5, +5.1] establishes non-inferiority. Under this analysis, the study met the clinical cure rate endpoint in the PPc population. Since p>0
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Contact: Melanie Nimrodi
mnimrodi@mww.com
312-546-3508
MWW Group
Source:Eurekalert

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