Safety and Efficacy of CEM-102 Compared to Linezolid in Acute Bacterial Skin Infections

Arrevus Inc.198 enrolled

Overview

The purpose of this study is to determine the safety and efficacy of CEM-102 compared to Linezolid in the treatment of acute bacterial skin structure infections (ABSSIs).

ABSSIs are common and affect all age groups. In recent years, ABSSIs caused by multi-drug resistant pathogens, especially methicillin-resistant Staphylococcus aureus (MRSA) have become more common. There is an urgent need for additional antibacterial drugs with modes of action different from those currently available. CEM-102 is one such agent with excellent activity against S. aureus, including MRSA.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

198

Conditions

Skin Diseases, Bacterial

Interventions

CEM-102DRUG

600 mg BID oral tablets for 10-14 days

LinezolidDRUG

600 mg BID oral tablets

CEM-102DRUG

1500 mg BID oral tablets on Day 1 followed by 600 mg BID oral tablets for a total of 10-14 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of acute bacterial skin-structure infection (ABSSI) of no more than 7 days duration which was suspected or proven to be caused, at least in part, by a gram-positive pathogen. * Eligible infections included cellulitis measuring at least 10 cm length and width or 100 cm squared, with or without a focal abscess, and surgical or traumatic wound infections * Infection which in the opinion of the investigator will require 10-14 days of antibacterial therapy. * Have at least 3 of the following local and/or systemic symptoms and/or signs of infection: purulent or seropurulent drainage/discharge, erythema, fluctuance, heat/localized warmth, pain/tenderness to palpation, swelling/induration, regional lymph node swelling or tenderness, temperature \>=100.4 degree F, increased white blood cell count, or bandemia. * Must not have received treatment with another systemic antibiotic for the current ABSSI. Exclusion Criteria: * Superficial skin structure infections such as folliculitis, carbuncles, furunculosis, cutaneous abscesses, and simple cellulitis. * Infections involving burns, human or animal bites, or chronic diabetic foot ulcers. * Suspected polymicrobial infection involving Pseudomonas aeruginosa * Anticipated need for \>14 days of antibiotic therapy. * Infections complicated by the presence of prosthetic materials that will not be removed, such as permanent cardiac pacemaker battery packs, mesh, or joint replacement prosthesis. * Known significant renal, hepatic, or hematologic impairment. * Received prior potentially effective antimicrobial therapy for the acute bacterial skin and skin structure infection, unless they were failing therapy after 48 hours or had a gram-positive pathogen non-susceptible to prior therapy identified as a causative pathogen.

Locations (16)

Unnamed facility

Chula Vista, California, United States

Unnamed facility

La Mesa, California, United States

Unnamed facility

Los Angeles, California, United States

Outcomes

Primary Outcomes

Clinical Success at Test of Cure (TOC) for the intent-to-treat (ITT) population

Meets the following definition for clinical success: continued complete resolution of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required

Time frame: 7 to 14 days after the last dose of study drug

Clinical Success at Test of Cure (TOC) for the clinically evaluable (CE) population

Meets the following definition for clinical success: continued complete resolution of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required

Time frame: 7 to 14 days after the last dose of study drug

Secondary Outcomes

Clinical Success at end of treatment (EOT) for the intent-to-treat (ITT) population

Meets the following definition for clinical success: Complete resolution of the signs and symptoms of the ABSSI and no further study drug therapy is required.

Time frame: 10-14 days of study drug

Clinical Success at the test of cure (TOC) in the microbiological intent-to-treat (MITT) and population

Meets the following definition for clinical success: Complete resolution of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required.

Time frame: 7 to 14 days after the last dose of study drug

Clinical Success at the end of treatment (EOT) for the Clinically evaluable (CE) population

Meets the following definition for clinical success: complete resolution of the signs and symptoms of the ABSSI and no further study drug therapy is required.

Time frame: 10-14 days of study drug

Clinical success at the end of treatment (EOT) for the microbiological intent-to-treat (MITT) population

Data from ClinicalTrials.gov

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Unnamed facility

Oceanside, California, United States

Unnamed facility

Oxnard, California, United States

Unnamed facility

Pasadena, California, United States

Unnamed facility

Santa Ana, California, United States

Unnamed facility

Torrance, California, United States

Unnamed facility

Torrance, California, United States

Unnamed facility

Columbus, Georgia, United States

...and 6 more locations

Meets the following definition for clinical success at the end of treatment: complete resolutoin of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required

Time frame: 10-14 days of study drug

Clinical Success at end of treatment (EOT) for the microbiologically evaluable (ME) population

Meets the following definition for clinical success: complete resolution of signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required.

Time frame: 10-14 days of study drug

Clinical Success at test of cure (TOC) for the microbiologically evaluable (ME) population

Meets the following definition of clinical success: continued complete resolution of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required.