In: Main9 Apr 2010
Speaker: Michael Corrado, MD, Physician of Infectious Diseases and President and Chief Executive Officer, Advanced Biologics, New Hope, Pennsylvania
Faropenem medoxomil (Orapem, Replidyne, Inc.), an investigative oral penem antibiotic with potent activity against Staphylococcus aureus and Streptococcus pyogenes, proved to be at least as effective as clavulanate (Augmentin canadian, GlaxoSmithKline) in the treatment of uncomplicated skin and skin structure infections (uSSSIs).
In a pivotal, prospective, double-blind clinical trial, 593 patients with a clinical diagnosis of uSSSI, particularly celluli-tis, impetigo, folliculitis, or furuncles, were enrolled from 40 centers in Europe, Israel, and South Africa between January 2001 and January 2002. These patients were randomly assigned to received oral faropenem medoxomil 300 mg twice daily for seven days or oral amoxicillin/clavulanate 625 mg three times daily for seven days.
These patients constituted the intent-to-treat (ITT) and safety populations. Of these patients, 246 receiving faropenem medoxomil and 227 receiving amoxicillin/clavulanate were evaluable for the primary efficacy outcome, and 154 patients receiving faropenem medoxomil and 139 receiving amoxi-cillin/clavulanate were microbiologically evaluable.
The primary objective of the study was met by showing that faropenem medoxomil was at least as effective as amoxi-cillin/clavulanate, at the dosages used, for clinical responses at the test-of-cure (TOC) visit at seven to 14 days of therapy. Clinical cure rates at the TOC visit were 91% with faropenem medoxomil and 91.2% with amoxicillin/clavulanate tablet.
Microbiological eradication rates were 91.6% with faropenem medoxomil and 90.6% with canadian amoxicillin/clavulanate. Bacteriological responses were as follows:
The overall safety of these two agents was similar, although diarrhea and nausea were two to three times higher in the patients receiving amoxicillin/clavulanate. Only five patients in the faropenem medoxomil group and six patients taking amoxicillin left the study prematurely because of an adverse drug effect (ADE). No deaths were reported.
Iclaprim Valuable Against Serious Complicated SSSI Infections
Speaker: Anton Leighton, MD, Medical Affairs, Arpida AG, Muenchenstein, Switzerland
Iclaprim (Arpida AG), a novel diaminopyrimidine antibiotic, has potent activity against a broad spectrum of gram-positive bacteria such as drug-resistant enterococci and methicillin-resistant Staphylococcus aureus (MRSA). It was observed to be as effective, or more so, than the standard of care therapy of vancomycin (Vancocin, Eli Lilly) for the treatment of severe hospital infections arising from infected ulcers, burns, and surgical wounds, otherwise known as complicated skin and skin structure infections (cSSSIs).
A phase 2 study was performed to determine the efficacy of iclaprim in patients with cSSSIs. Ninety-two patients were randomly assigned to receive either iclaprim 0.8 mg/kg or 1.6 mg/kg intravenously (IV) twice daily for 10 days or IV vancomycin 1 g twice a day for 10 days.
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The test-of-cure (TOC) rates were 92.9% for low-dose iclaprim, 90.3% for high-dose iclaprim, and 92.9% for vanco-mycin. The drug was well tolerated in these patients, and no drug-related or severe ADEs were observed. Minor ADEs were of little or no clinical significance; they were infrequent and of mild or moderate intensity.
Eradication rates of gram-positive pathogens were 90% for iclaprim 0.8 mg/kg, 80% for iclaprim 1.6 mg/kg, and 72% for vancomycin. S. aureus, as expected, was the most frequent
gram-positive pathogen. Eradication rates were much higher with iclaprim (72%-80%) than with vancomycin (59%).
At the baseline evaluation, there were five cases of MRSA (in four patients receiving iclamprim 0.8 mg/kg and in one patient receiving vancomycin). At the TOC visit, all MRSA organisms were eradicated in the iclaprim-treated patients.
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Based on these results, the U.S. Food and Drug Administration granted iclaprim a fast-track designation because it is being developed to treat potentially life-threatening infections (including those caused by MRSA) and because it may benefit patients who cannot tolerate existing therapies.
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