NCT02570490

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 716 (actual)
• Sponsor: Arrevus Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Acute Bacterial Skin and Skin Structure Infections

Interventions

Type	Name	Description
DRUG	sodium fusidate
DRUG	linezolid

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2015-10-07
• Last updated: 2019-04-19

Locations

62 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study