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

A Phase 2, Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Contezolid Acefosamil Compared to Linezolid Administered Intravenously and Orally to Adult Subjects With Acute Bacterial Skin and Skin Structure Infection

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

Study Overview

• Status: Completed
• Conditions: Gram-Positive Bacterial Infections; Skin Diseases, Bacterial
• Intervention / Treatment: Drug: contezolid acefosamil; Drug: linezolid 600 mg

• Study Type: Interventional
• Enrollment (Actual): 196
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Chula Vista, California, United States, 91911
      • MicuRx Site #106
    • La Mesa, California, United States, 91942
      • MicuRx Site #103
    • Long Beach, California, United States, 90806
      • MicuRx Site #102
    • Stockton, California, United States, 95204
      • MicuRx Site #104
  • Montana
    • Butte, Montana, United States, 59701
      • MicuRx Site #107
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • MicuRx Site #105
    • Las Vegas, Nevada, United States, 89109
      • MicuRx Site #108

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: contezolid acefosamil; 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	Drug: contezolid acefosamil; IV and oral contezolid acefosamil given twice a day for 10 to 14 days
Active Comparator: linezolid; linezolid 600 mg IV q12h for at least 3 total IV doses, followed by 600 mg PO q12h for 10 to 14 days	Drug: linezolid 600 mg; IV and oral linezolid given twice a day for 10 to 14 days; Other Names: Zyvox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early Clinical Response at the Early Assessment Visit (ITT Population)	Early clinical response assessment based on the electronic case report form (eCRF) data at Early Assessment (48-72 hours after start of study drug) where a successful response (i.e., "responder") was defined as a reduction in primary ABSSSI lesion size ≥20% compared to baseline, and the subject did not receive a non-protocol specified systemic antibacterial agent with activity against Gram-positive organisms for the treatment of ABSSSI and did not die of any cause up to Early Assessment.	48 to 72 hours after the start of study drug

Collaborators and Investigators

• Sponsor: MicuRx

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2018
• Primary Completion (Actual): March 26, 2019
• Study Completion (Actual): March 26, 2019

Study Registration Dates

• First Submitted: November 12, 2018
• First Submitted That Met QC Criteria: November 16, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: October 16, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: ABSSSI; Acute bacterial skin and skin structure infection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Infections; Communicable Diseases; Skin Diseases; Bacterial Infections; Skin Diseases, Bacterial; Gram-Positive Bacterial Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Linezolid
• Other Study ID Numbers: MRX4-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No