Oral Sodium Fusidate (CEM-102) Versus Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Acute Bacterial Skin and Skin Structure Infections Clinical Trial

Official title: A Randomized, Double-blind, Multi-center Study to Evaluate the Safety and Efficacy of Oral Sodium Fusidate (CEM-102) Compared to Oral Linezolid in the Treatment of Acute Bacterial Skin and Skin Structure Infections

Status Completed

Clinical Trial Summary

Phase 3, randomized, double-blind, multi-center efficacy and safety study to evaluate an oral CEM-102 loading dose regimen compared to oral linezolid in the treatment of subjects with ABSSSI

Clinical Trial Description

The primary objective is to demonstrate the non-inferiority of oral CEM-102 (loading dose regimen of 1500 mg every 12 hours for 2 doses, followed by 600 mg every 12 hours thereafter) compared to oral linezolid (600 mg every 12 hours), each administered for 10 days, for Early Clinical Response (ECR) in the intent to treat (ITT) analysis set in subjects with acute bacterial skin and skin structure infections (ABSSSI). Subjects with an ABSSSI caused by suspected or documented Gram-positive pathogen(s) at baseline will be randomized 1:1 to study treatment ;

Related Conditions & MeSH terms

• Acute Bacterial Skin and Skin Structure Infections
• Communicable Diseases
• Infection
• Skin Diseases, Bacterial

• NCT number: NCT02570490
• Study type: Interventional
• Source: Arrevus Inc.
• Status: Completed
• Phase: Phase 3
• Start date: November 2015
• Completion date: November 2016