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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arrevus Inc.; Cempra Inc
• Treatments: Fusidic Acid; Linezolid

Criteria

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.