Safety and Efficacy of CEM-102 Compared to Linezolid in Acute Bacterial Skin Infections

• Clinical Success at Test of Cure (TOC) for the intent-to-treat (ITT) population [ Time Frame: 7 to 14 days after the last dose of study drug ] [ Designated as safety issue: No ]
  Meets the following definition for clinical success: continued complete resolution of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required
• Clinical Success at Test of Cure (TOC) for the clinically evaluable (CE) population [ Time Frame: 7 to 14 days after the last dose of study drug ] [ Designated as safety issue: No ]
  Meets the following definition for clinical success: continued complete resolution of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required

• Clinical Success at end of treatment (EOT) for the intent-to-treat (ITT) population [ Time Frame: 10-14 days of study drug ] [ Designated as safety issue: No ]
  Meets the following definition for clinical success: Complete resolution of the signs and symptoms of the ABSSI and no further study drug therapy is required.
• Clinical Success at the test of cure (TOC) in the microbiological intent-to-treat (MITT) and population [ Time Frame: 7 to 14 days after the last dose of study drug ] [ Designated as safety issue: No ]
  Meets the following definition for clinical success: Complete resolution of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required.
• Clinical Success at the end of treatment (EOT) for the Clinically evaluable (CE) population [ Time Frame: 10-14 days of study drug ] [ Designated as safety issue: No ]
  Meets the following definition for clinical success: complete resolution of the signs and symptoms of the ABSSI and no further study drug therapy is required.
• Clinical success at the end of treatment (EOT) for the microbiological intent-to-treat (MITT) population [ Time Frame: 10-14 days of study drug ] [ Designated as safety issue: No ]
  Meets the following definition for clinical success at the end of treatment: complete resolutoin of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required
• Clinical Success at end of treatment (EOT) for the microbiologically evaluable (ME) population [ Time Frame: 10-14 days of study drug ] [ Designated as safety issue: No ]
  Meets the following definition for clinical success: complete resolution of signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required.
• Clinical Success at test of cure (TOC) for the microbiologically evaluable (ME) population [ Time Frame: 7-14 days after the last dose of study drug ] [ Designated as safety issue: No ]
  Meets the following definition of clinical success: continued complete resolution of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required.
• Clinical success at the test of cure (TOC) by baseline pathogen for the microbiological intent-to-treat (MITT) population [ Time Frame: 7-14 days after the last dose of study drug ] [ Designated as safety issue: No ]
  Meets the following definition for clinical success: continued complete resolution of the signs and symptoms of the ABSSI and no additonal systemic antibacterial therapy is required
• Clinical success at test of cure (TOC) by baseline pathogen for the microbiologically evaluable (ME) population [ Time Frame: 7 to 14 days after the last dose of study drug ] [ Designated as safety issue: No ]
  Meets the following definition for clinical success: continued complete resolution of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required
• By-pathogen microbiological success at test of cure (TOC) for the microbiological intent-to-treat (MITT) population [ Time Frame: 7-14 days after the last dose of study drug ] [ Designated as safety issue: No ]

  Successful responses included:

  eradication: the basline causative pathogen was absent from the culture(s) presumed eradication: the patient's clincial response was success, and no culture available.

• By-pathogen microbiological success at test of cure (TOC) for the microbiologically evaluable (ME) population [ Time Frame: 7-14 days after the last dose of study drug ] [ Designated as safety issue: No ]

  Successful responses included:

  eradication: the basline causative pathogen was absent from the culture(s) presumed eradication: the patient's clincial response was success, and no culture available.

• By-patient microbiological success at test of cure (TOC) for the microbiological intent-to-treat (MITT) population [ Time Frame: 7-14 days after the last dose of study drug ] [ Designated as safety issue: No ]

  Successful responses included:

  eradication: the baseline causative organisms have a response of eradication. presumed eradication: all baseline causative organism(s) have a response of presumed eradication combined eradication/presumed eradication: in cases where baseline causative organisms were from a blood and an ABSSI culture

• By-patient microbiological success at test of cure (TOC) for the microbiologically evaluable (ME) population [ Time Frame: 7-14 days after the last dose of study drug ] [ Designated as safety issue: No ]

  Successful responses included:

  eradication: the baseline causative organisms have a response of eradication. presumed eradication: all baseline causative organism(s) have a response of presumed eradication combined eradication/presumed eradication: in cases where baseline causative organisms were from a blood and an ABSSI culture

• Clinical Response in the Microbiological ITT (MITT), CE, and Microbiologically Evaluable (ME) populations at end of treatment (EOT) [ Time Frame: 16 months ] [ Designated as safety issue: No ]
• Clinical Response in the MITT and ME populations at TOC [ Time Frame: 16 months ] [ Designated as safety issue: No ]
• By patient and by pathogen Microbiological Response in the MITT and ME populations at EOT and TOC [ Time Frame: 16 months ] [ Designated as safety issue: No ]

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.

• Drug: CEM-102
  600 mg BID oral tablets for 10-14 days
  Other Name: fusidic acid
• Drug: Linezolid
  600 mg BID oral tablets
  Other Name: Zyvox
• Drug: CEM-102
  1500 mg BID oral tablets on Day 1 followed by 600 mg BID oral tablets for a total of 10-14 days
  Other Name: fusidic acid

• Active Comparator: Linezolid
  600 mg BID
  Intervention: Drug: Linezolid
• Experimental: CEM-102 Regimen A
  Intervention: Drug: CEM-102
• Experimental: CEM-102 Regimen B
  Intervention: Drug: CEM-102

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.