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

Completed · Phase 2

Conditions studied: Skin Diseases, Bacterial

In brief

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).

Key facts

Study ID

NCT00948142

Run by

Arrevus Inc.

People needed

198

Starts

2009-08-01

Expected to finish

2010-03-01

Last updated by the study team

2019-04-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Chula Vista, California, United States
• Study site — La Mesa, California, United States
• Study site — Los Angeles, California, United States
• Study site — Oceanside, California, United States
• Study site — Oxnard, California, United States
• Study site — Pasadena, California, United States
• Study site — Santa Ana, California, United States
• Study site — Torrance, California, United States
• Study site — Torrance, California, United States
• Study site — Columbus, Georgia, United States
• Study site — Savannah, Georgia, United States
• Study site — Springfield, Illinois, United States
• Study site — Detroit, Michigan, United States
• Study site — Butte, Montana, United States
• Study site — Somers Point, New Jersey, United States
• Study site — Akron, Ohio, United States

Full record on ClinicalTrials.gov

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