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

.05, there is not a statistically significant difference between cethromycin and Biaxin, which supports non-inferiority.

  • Modified intent-to-treat clinical cure rate (mITT)- cethromycin 83.1% (217 subjects/261 subjects) compared to Biaxin 81.1% (206 subjects/254 subjects) [-4.8, +8.9] (p=0.5667). mITT is defined as subjects who received at least one dose of study medication and had a clinical diagnosis consistent with bacterial CAP confirmed by a positive pre-treatment chest X-ray and appropriate signs/symptoms. Based on the 83.1% clinical cure rate for cethromycin being between 80% and 90%, a delta value of 15% or less on the lower bound and greater than zero on the upper bound [-4.8, +8.9] establishes non-inferiority. Under this analysis, the study met the clinical cure rate endpoint in the mITT population. Since p>0.05, there is not a statistically significant difference between cethromycin and Biaxin, which supports non-inferiority.

  • Per protocol radiographic success rate- cethromycin 92.7% (202 subjects/218 subjects) compared to Biaxin 92.3% (192 subjects/208 subjects) [-4.9, +5.6] (p>0.9999). Based on the 92.7% radiographic success 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 [-4.9, +5.6] establishes non-inferiority. Under this analysis, the study met the radiographic success rate endpoint in the PPc population. Since p>0.05, there is not a statistically significant difference between cethromycin and Biaxin, which supports non-inferiority.

  • Modified intent-to-treat radiographic success rate- cethromycin 82.4% (215 subjects/261 subjects) compared to Biaxin 81.5% (207 subjects/254 subjects) [-6.0, +7.7] (p=0.8195). Based on the 82.4% radiographic success rate for cethromycin being between 80% and 90%, a delta value of 15% or less on the lower bound and greater than zero on the upper bound [-6.0, +7.7]
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Contact: Melanie Nimrodi
mnimrodi@mww.com
312-546-3508
MWW Group
Source:Eurekalert

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