NCT02607618

Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-2

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-2

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 613 (actual)
• Sponsor: Motif Bio · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter, randomized, double-blind study of the efficacy and safety of IV iclaprim compared to IV 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).

Conditions

• Skin Structures and Soft Tissue Infections

Interventions

Type	Name	Description
DRUG	Iclaprim	Experimental treatment
DRUG	Vancomycin	Active comparator

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-08-08
• Completion: 2017-08-08
• First posted: 2015-11-18
• Last updated: 2018-08-07
• Results posted: 2018-07-11

Locations

54 sites across 10 countries: United States, Argentina, Belgium, Croatia, Czechia, Estonia, Hungary, Portugal, Romania, Turkey (Türkiye)