NCT00428844

Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci

A Phase 2 Randomized Study Investigating the Safety, Efficacy and Pharmacokinetics of Daptomycin 6 mg/kg and 8 mg/kg Versus Comparator in the Treatment of Subjects Undergoing Surgical Standard of Care for Osteomyelitis Associated With an Infected Prosthetic Hip or Knee Joint Caused by Staphylococci

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a research study designed to look at the efficacy and safety of daptomycin given at a dose of 6 mg/kg or 8 mg/kg in subjects being treated for prosthetic hip or knee infections caused by Staphylococci. These types of bacteria are among the most common types of bacteria causing infections of prosthetic joints.

Conditions

• Osteomyelitis

Interventions

Type	Name	Description
DRUG	daptomycin	6 mg/kg
DRUG	daptomycin	8 mg/kg
DRUG	vancomycin	1 gram
DRUG	teicoplanin	6 mg/kg; used only at UK sites
DRUG	nafcillin	1-2 gram
DRUG	oxacillin	1-2 gram
DRUG	flucloxacillin	1-2 mg

Timeline

• Start date: 2007-06-26
• Primary completion: 2010-03-26
• Completion: 2010-06-23
• First posted: 2007-01-30
• Last updated: 2018-01-31
• Results posted: 2011-06-14

Locations

26 sites across 3 countries: United States, Russia, United Kingdom