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

Phase 2

Completed

• Conditions: Skin Diseases, Bacterial; Gram-Positive Bacterial Infections
• Interventions: Drug: contezolid acefosamil; Drug: linezolid 600 mg

• Registration Number: NCT03747497
• Lead Sponsor: MicuRx

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-12
• Study Start: 2018-11-15
• Study First Submitted QC: 2018-11-16
• Study First Posted: 2018-11-20
• Primary Completion: 2019-03-26
• Study Completion: 2019-03-26
• Results First Submitted: 2021-04-06
• Results First Submitted QC: 2021-04-06
• Results First Posted: 2021-04-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-16
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
contezolid acefosamil	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
linezolid	linezolid 600 mg	linezolid 600 mg IV q12h for at least 3 total IV doses, followed by 600 mg PO q12h for 10 to 14 days

Primary Outcome Measures

Name	Time	Method
Early Clinical Response at the Early Assessment Visit (ITT Population)	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.

Trial Locations

Locations (7)

MicuRx Site #107; 🇺🇸 Butte, Montana, United States

MicuRx Site #106; 🇺🇸 Chula Vista, California, United States

MicuRx Site #103; 🇺🇸 La Mesa, California, United States

MicuRx Site #102; 🇺🇸 Long Beach, California, United States

MicuRx Site #105; 🇺🇸 Las Vegas, Nevada, United States

MicuRx Site #104; 🇺🇸 Stockton, California, United States

MicuRx Site #108; 🇺🇸 Las Vegas, Nevada, United States