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

Arrevus

Status and phase: Completed; Phase 2

Conditions: Skin Diseases, Bacterial

Treatments: Drug: CEM-102; Drug: Linezolid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00948142

CE06-300

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 198 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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198 participants in 3 patient groups

Linezolid

Active Comparator group

Description:

600 mg BID

Treatment:

Drug: Linezolid

CEM-102 Regimen A

Experimental group

Treatment:

Drug: CEM-102

Drug: CEM-102

CEM-102 Regimen B

Experimental group

Treatment:

Drug: CEM-102

Drug: CEM-102