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NCT03747497 Clinical Trial

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

Gram-Positive Bacterial Infections Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03747497
Other study ID # MRX4-201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 15, 2018
Est. completion date March 26, 2019

Study information
Verified date October 2022
Source MicuRx
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 196
Est. completion date March 26, 2019
Est. primary completion date March 26, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• contezolid acefosamil
IV and oral contezolid acefosamil given twice a day for 10 to 14 days
• linezolid 600 mg
IV and oral linezolid given twice a day for 10 to 14 days

Locations
Country Name City State
United States 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 #105 Las Vegas Nevada
United States MicuRx Site #108 Las Vegas Nevada
United States MicuRx Site #102 Long Beach California
United States MicuRx Site #104 Stockton California

Sponsors (1)
Lead Sponsor Collaborator
MicuRx

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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