NCT00948142

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: Arrevus Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Skin Diseases, Bacterial

Interventions

Type	Name	Description
DRUG	CEM-102	600 mg BID oral tablets for 10-14 days
DRUG	Linezolid	600 mg BID oral tablets
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

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2009-07-29
• Last updated: 2019-04-19

Locations

16 sites across 1 country: United States