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Phase III data show efficacy/safety of iclaprim in patients with complicated skin infections
Date:10/27/2008

id, both administered intravenously twice daily and analyzed based on populations, including intent-to-treat (ITT), modified intent-to-treat (MITT), per protocol (PP) and modified clinical evaluable (MCE).
  • The ITT population included all patients who received at least one dose of medication;
  • The MITT population included all patients in the ITT population who had an infecting Gram-positive pathogen isolated at baseline;
  • The PP population excludes all patients with any protocol violation; and
  • The MCE population was the same as the PP population, but adding back clinically evaluable patients whose protocol violation was use of additional systemic or topical prohibited antibiotics or high-dose steroids registered as clinical failures.

The causative pathogen distribution in the study population was well-balanced between treatment groups with Staphylococcus aureus (S. aureus) as the predominant pathogen isolated at baseline (76.5 percent for iclaprim and 81.1 percent for linezolid), of which 40 percent of isolates were MRSA.

Patients were evaluated daily for the first four days and then every other day thereafter during the treatment period, at the end of therapy, at the test-of-cure (TOC) visit (7 to 14 days post treatment) and at a late follow-up visit 7 to14 days after the TOC visit. The primary endpoint was the comparative clinical cure rates of iclaprim and linezolid at the TOC visit in the ITT and PP populations.

The most commonly reported adverse events in the clinical studies were: gastrointestinal disorders (7.4 percent versus 10.4 percent for iclaprim and linezolid, respectively); general disorders and administration site conditions (4.2 percent versus 3.9 percent); nervous system disorders (4.8 percent versus 6.5 percent); and skin and subcutaneous tissue disorders (4.2 percent versus 4.5 percent).


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Contact: Dr. Jrgen Raths
41-614-179-660
Zeno Group
Source:Eurekalert

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