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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-15

Study Completion Date

2019-03-26

Brief Summary

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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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Detailed Description

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Conditions

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Skin Diseases, Bacterial Gram-Positive Bacterial Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

contezolid acefosamil

Intervention Type DRUG

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

linezolid

linezolid 600 mg IV q12h for at least 3 total IV doses, followed by 600 mg PO q12h for 10 to 14 days

Group Type ACTIVE_COMPARATOR

linezolid 600 mg

Intervention Type DRUG

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

Interventions

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contezolid acefosamil

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

Intervention Type DRUG

linezolid 600 mg

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

Intervention Type DRUG

Other Intervention Names

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Zyvox

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No