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OpenTrials
Completed

NCT Number: NCT02269319

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

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

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Key information

Conditions

Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRX-I

Drug

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

Linezolid

Drug

Oral linezolid 600mg given twice a day for 10 days

Other names: Zyvox

Primary outcomes

  1. Number of Patients at the Early Assessment Visit With a 20% Reduction in ABSSSI Lesion Size Compared to Baseline

    Time frame: 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 outcomes

  1. Number of Patients at EOT With a 80% Reduction in ABSSSI Lesion Size Compared to Baseline

    Time frame: Day 10

Sponsors and collaborators

Lead sponsor

MicuRx

Industry

Registry information

Official study title

A Phase 2, Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of MRX-I Versus Linezolid in Adult Subjects With Acute Bacterial Skin and Skin Structure Infection

Acronym: ABSSSI

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 21, 2014
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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