Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-1 — REVIVE-1  

Skin Structures and Soft Tissue Infections Clinical Trial

Official title: A Phase 3, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Iclaprim Versus Vancomycin in the Treatment of ABSSSI: REVIVE-1

Status Completed

Clinical Trial Summary

This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim compared to vancomycin for the treatment of skin and skin structure infections.

Clinical Trial Description

This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim compared to vancomycin. Patients will receive either iclaprim or vancomycin for 5 to 14 days. Patients will be evaluated daily up to early time point (ETP), then every 48 to 72 hours through the end of treatment. Patients will also be evaluated at the test of cure (TOC) visit (7 to 14 days post-EOT), and will have a Late Follow-Up (LFU) visit (28 to 32 days post-first dose). ;

Related Conditions & MeSH terms

• Skin Structures and Soft Tissue Infections
• Soft Tissue Infections

• NCT number: NCT02600611
• Study type: Interventional
• Source: Motif Bio
• Status: Completed
• Phase: Phase 3
• Start date: November 1, 2015
• Completion date: January 30, 2017