Contezolid Acefosamil Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection

MicuRx

Status and phase: Completed; Phase 2

Conditions: Skin Diseases, Bacterial; Gram-Positive Bacterial Infections

Treatments: Drug: contezolid acefosamil; Drug: linezolid 600 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03747497

MRX4-201

Details and patient eligibility

About

The purpose of this study is to determine whether contezolid acefosamil is as safe and effective as linezolid in the treatment of adult patients with acute bacterial skin and skin structure infections

Enrollment: 196 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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196 participants in 2 patient groups

contezolid acefosamil

Experimental group

Description:

contezolid acefosamil 1500 mg IV x 1 dose, followed by 1000 mg IV q12h for at least 3 total IV doses, followed by 1300 mg PO q12h for 10 to 14 days

Treatment:

Drug: contezolid acefosamil

linezolid

Active Comparator group

Description:

linezolid 600 mg IV q12h for at least 3 total IV doses, followed by 600 mg PO q12h for 10 to 14 days

Treatment:

Drug: linezolid 600 mg