Phase 2a Study of CG400549 for the Treatment of cABSSSI Caused by Methicillin-resistant Staphylococcus Aureus
Phase 2a Study of CG400549 for the Treatment of cABSSSI Caused by Methicillin-resistant Staphylococcus Aureus
Primary Objective:

 To make a preliminary assessment of the efficacy of CG400549 (960 mg daily) in subjects with
 cABSSSI (major cutaneous abscesses) due to MRSA.

 Secondary Objective(s):

 -  To assess the pharmacokinetics of CG400549 (960 mg daily) in subjects with cABSSSI due
 to MRSA

 -  To explore the in vitro susceptibility of cABSSSI-related bacteria to CG400549.

 -  To assess the safety of multiple doses of CG400459
This will be an open-label, exploratory study to evaluate the safety, pharmacokinetics, and
 efficacy of CG400549, daily for 10 to 14 days, in subjects with cABSSSI (major cutaneous
 abscesses) due to MRSA. All subjects will receive active treatment.

 Subjects will begin study treatment upon confirmation of clinical eligibility (ie,
 confirmation of MRSA infection is not required pretreatment). Subjects who begin treatment
 with CG400549 and are subsequently not found to have S. aureus infection will be discontinued
 from study treatment, treated as appropriate for the identified pathogen(s), and followed for
 safety. These subjects will be included in the safety analyses but not in the primary
 efficacy analysis.
Inclusion Criteria:

 1. Diagnosis of major cutaneous abscess suspected or confirmed to be caused by a MRSA.

 2. Signs and symptoms should include at least 2 of the following: purulent drainage or
 discharge, erythema, fluctuance, heat or localized warmth, edema/induration, pain or
 tenderness to palpation

 Exclusion Criteria:

 1. Prior systemic or topical antibacterial therapy

 2. Severe sepsis or refractory shock