At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 75 enrolled
Drug / intervention
daptomycin +6 moredrug
Likely dose
daptomycin 6 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·interventional·Posted Jan 30, 2007·Updated Jan 31, 2018
In Brief
A Phase 2 clinical trial evaluating daptomycin, vancomycin, and 4 other interventions for Osteomyelitis. Completed, enrolled 75 participants across 26 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteomyelitis
CountriesRussia, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 2007
Enrollment StartJun 2007
Primary CompletionMar 2010
Study CompletionJun 2010
TodayJul 2026
First PostedJan 30, 2007
Enrollment StartJun 26, 2007
Primary CompletionMar 26, 2010
Study CompletionJun 23, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 19.4 years ago
Interventions
daptomycindrug
6 mg/kg
daptomycindrug
8 mg/kg
vancomycindrug
1 gram
teicoplanindrug
6 mg/kg; used only at UK sites
nafcillindrug
1-2 gram
oxacillindrug
1-2 gram
flucloxacillindrug
1-2 mg