MRX-I Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection
- Registration Number
- NCT02269319
- Lead Sponsor
- MicuRx
- Brief Summary
The purpose of this study is to determine whether MRX-I is as safe and effective as Linezolid in the treatment of adult patients with acute bacterial skin and skin structure infections
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- Patients with systemic signs of infection diagnosed with acute bacterial skin and skin structure infection (ABSSSI)
- Diagnosed with Cellulitis/ erysipelas, major cutaneous abscess, or wound infections
Exclusion Criteria
- Uncomplicated skin infections
- Severe sepsis or septic shock
- ABSSSI solely due to gram-negative pathogens
- Prior systemic antibiotics within 96 hours of randomization
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MRX-I MRX-I MRX-I tablets 800 mg given twice a day for 10 days Linezolid Linezolid Linezolid 600 mg given twice a day for 10 days
- Primary Outcome Measures
Name Time Method Number of Patients at the Early Assessment Visit With a 20% Reduction in ABSSSI Lesion Size Compared to Baseline 48-72 hours * Did not receive a systemic antibacterial agent with activity against gram-positive organisms
* Did not die of any cause up to EA
- Secondary Outcome Measures
Name Time Method Number of Patients at EOT With a 80% Reduction in ABSSSI Lesion Size Compared to Baseline Day 10