Safety and Efficacy of CEM-102 Compared to Linezolid in Acute Bacterial Skin Infections
Safety and Efficacy of CEM-102 Compared to Linezolid in Acute Bacterial Skin Infections
The purpose of this study is to determine the safety and efficacy of CEM-102 compared to
 Linezolid in the treatment of acute bacterial skin structure infections (ABSSIs).
ABSSIs are common and affect all age groups. In recent years, ABSSIs caused by multi-drug
 resistant pathogens, especially methicillin-resistant Staphylococcus aureus (MRSA) have
 become more common. There is an urgent need for additional antibacterial drugs with modes of
 action different from those currently available. CEM-102 is one such agent with excellent
 activity against S. aureus, including MRSA.
Inclusion Criteria:

 -  Diagnosis of acute bacterial skin-structure infection (ABSSI) of no more than 7 days
 duration which was suspected or proven to be caused, at least in part, by a
 gram-positive pathogen.

 -  Eligible infections included cellulitis measuring at least 10 cm length and width or
 100 cm squared, with or without a focal abscess, and surgical or traumatic wound
 infections

 -  Infection which in the opinion of the investigator will require 10-14 days of
 antibacterial therapy.

 -  Have at least 3 of the following local and/or systemic symptoms and/or signs of
 infection: purulent or seropurulent drainage/discharge, erythema, fluctuance,
 heat/localized warmth, pain/tenderness to palpation, swelling/induration, regional
 lymph node swelling or tenderness, temperature >=100.4 degree F, increased white blood
 cell count, or bandemia.

 -  Must not have received treatment with another systemic antibiotic for the current
 ABSSI.

 Exclusion Criteria:

 -  Superficial skin structure infections such as folliculitis, carbuncles, furunculosis,
 cutaneous abscesses, and simple cellulitis.

 -  Infections involving burns, human or animal bites, or chronic diabetic foot ulcers.

 -  Suspected polymicrobial infection involving Pseudomonas aeruginosa

 -  Anticipated need for >14 days of antibiotic therapy.

 -  Infections complicated by the presence of prosthetic materials that will not be
 removed, such as permanent cardiac pacemaker battery packs, mesh, or joint replacement
 prosthesis.

 -  Known significant renal, hepatic, or hematologic impairment.

 -  Received prior potentially effective antimicrobial therapy for the acute bacterial
 skin and skin structure infection, unless they were failing therapy after 48 hours or
 had a gram-positive pathogen non-susceptible to prior therapy identified as a
 causative pathogen.