MRX-I Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

MicuRx

Status and phase: Completed; Phase 2

Conditions: Bacterial Infections

Treatments: Drug: MRX-I; Drug: Linezolid

Study type: Interventional

Funder types: Industry

Identifiers

NCT02269319

MRX-I-03

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

MRX-I

Experimental group

Description:

MRX-I tablets 800 mg given twice a day for 10 days

Treatment:

Drug: MRX-I

Linezolid

Active Comparator group

Description:

Linezolid 600 mg given twice a day for 10 days

Treatment:

Drug: Linezolid