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Completed

NCT Number: NCT03747497

Contezolid Acefosamil Versus Linezolid for the Treatment of 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

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Key information

Conditions

Skin Diseases, Bacterial Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

MicuRx Site #106, Chula Vista, California, United States

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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

contezolid acefosamil

Drug

IV and oral contezolid acefosamil given twice a day for 10 to 14 days

Linezolid 600 mg

Drug

IV and oral linezolid given twice a day for 10 to 14 days

Other names: Zyvox

Primary outcomes

  1. Early Clinical Response at the Early Assessment Visit (ITT Population)

    Time frame: 48 to 72 hours after the start of study drug

    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.

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 Contezolid Acefosamil Compared to Linezolid Administered Intravenously and Orally to Adult Subjects With Acute Bacterial Skin and Skin Structure Infection

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 20, 2018
Registry last updated
Nov 8, 2022

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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