Overview
Phase 2a Study of CG400549 for the Treatment of cABSSSI Caused by Methicillin-resistant Staphylococcus Aureus
Status:
Completed
Completed
Trial end date:
2012-10-01
2012-10-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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 CG400459Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
CrystalGenomics, Inc.Treatments:
Methicillin
Criteria
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