Phase 2 N=196 Randomized Double-blind Treatment

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

Skin Diseases, Bacterial · Gram-Positive Bacterial Infections

Bottom Line

View on ClinicalTrials.gov: NCT03747497 ↗

Enrolled (actual)

196

Serious AEs

2.1%

Results posted

Apr 2021

Primary outcome: Primary: Early Clinical Response at the Early Assessment Visit (ITT Population) — 102; 51; 3; 6 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: contezolid acefosamil (Drug); linezolid 600 mg (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: MicuRx
Primary completion: Mar 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Early Clinical Response at the Early Assessment Visit (ITT Population)	102; 51; 3; 6; 26; 8	—

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03747497). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.