Phase 2a Study of CG400549 for the Treatment of cABSSSI Caused by Methicillin-resistant Staphylococcus Aureus
To make a preliminary assessment of the efficacy of CG400549 (960 mg daily) in subjects with cABSSSI (major cutaneous abscesses) due to MRSA.
- 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
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 2a, Repeated-dose, Open-label, Single-arm Study of CG400549 for the Treatment of Complicated Acute Bacterial Skin and Skin Structure Infection (cABSSSI) Caused by Methicillin-resistant Staphylococcus Aureus (MRSA)|
- To make a preliminary assessment of the efficacy of CG400549 (960 mg daily) in subjects with cABSSSI (major cutaneous abscesses) due to MRSA. [ Time Frame: at 48 to 72 hours after enrollment ] [ Designated as safety issue: Yes ]The primary efficacy endpoint will be cessation of the spread of the redness, edema, and/or induration of the lesion or reduction in the size of redness, edema, and/or induration at 48 to 72 hours after enrollment and absence of fever in the microbiological modified intent-to-treat population.
- • To explore the in vitro susceptibility of cABSSSI-related bacteria to CG400549. [ Time Frame: [10~14days], [28days] ] [ Designated as safety issue: Yes ]Clinical cure and microbial eradication rates, in the clinically evaluable (CE) and microbiologically evaluable (ME) populations, respectively, at EOT and TOC.
|Study Start Date:||June 2012|
|Study Completion Date:||October 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Experimental: Single Arm for CG400549
All the patients will be administered with CG400549.
960mg QD at fed state approx 1 hour after meal
Other Name: CG400549
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.