NCT01175707

Study Comparing Cubicin With Vancomycin in Treatment of Participants With Complicated Skin and Skin Structure Infections in a Home Infusion Setting

A Phase 4, Prospective, Randomized, Open-label Study to Compare Use of Cubicin With Vancomycin Administered Intravenously in the Treatment of Patients With Complicated Skin and Skin Structure Infections Due to Suspected or Confirmed Gram-positive Bacteria in a Home Infusion Setting

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label, multi-center, phase 4 study designed to compare intravenous (IV) daptomycin and IV vancomycin administered in a home infusion setting for the treatment of complicated skin and skin structure infections (cSSSI) due to Gram-positive bacteria in participants who are prescribed vancomycin for 7 to 14 days and who are planning to receive vancomycin in a home-infusion setting.

Detailed description

This is a randomized, open-label, multi-center, phase 4 study. The overall goals of this study are to compare intravenous (IV) daptomycin and IV vancomycin administered in a home infusion setting for the treatment of cSSSI due to Gram-positive bacteria in participants who are prescribed vancomycin for 7-14 days and who are planning to receive vancomycin in a home infusion setting. Study objectives include evaluation of clinical and resource utilization endpoints and economic analysis from the perspective of the home infusion provider.

Conditions

• Complicated Skin or Skin Structure Infection

Interventions

Type	Name	Description
DRUG	Daptomycin
DRUG	Vancomycin

Timeline

• Start date: 2010-07-15
• Primary completion: 2011-11-17
• Completion: 2011-11-17
• First posted: 2010-08-05
• Last updated: 2018-12-26
• Results posted: 2015-05-13

Locations

4 sites across 1 country: United States