Trial | NCT00948142  Report issue

Title

Safety and Efficacy of CEM-102 Compared to Linezolid in Acute Bacterial Skin Infections
A Phase 2, Randomized, Double-blind, Multi-center Study to Evaluate the Safety and Efficacy of CEM-102 Compared to Linezolid in the Treatment of Acute Bacterial Skin Structure Infections

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    198
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 Started
Aug 31
2009
Primary Completion
Mar 31
2010
Study Completion
Mar 31
2010
Last Update
Apr 19
2019

Drug CEM-102

600 mg BID oral tablets for 10-14 days

  • Other names: fusidic acid

Drug Linezolid

600 mg BID oral tablets

  • Other names: Zyvox

Drug CEM-102

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

  • Other names: fusidic acid

Linezolid Active Comparator

600 mg BID

CEM-102 Regimen A Experimental

CEM-102 Regimen B Experimental

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.
No Results Posted