Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci
|ClinicalTrials.gov Identifier: NCT00428844|
Recruitment Status : Completed
First Posted : January 30, 2007
Results First Posted : June 14, 2011
Last Update Posted : January 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Osteomyelitis||Drug: daptomycin Drug: vancomycin Drug: teicoplanin Drug: nafcillin Drug: oxacillin Drug: flucloxacillin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||June 26, 2007|
|Actual Primary Completion Date :||March 26, 2010|
|Actual Study Completion Date :||June 23, 2010|
Experimental: Daptomycin 6 mg/kg
Daptomycin (6 mg/kg every 24 hours [q24h]) as a 30 minute intravenous (IV) infusion for 6 weeks (± one week).
Other Name: Cubicin
Experimental: Daptomycin 8 mg/kg
Daptomycin (8 mg/kg q24h) as a 30 minute IV infusion for 6 weeks (± one week).
Other Name: Cubicin
Active Comparator: Comparator
Vancomycin was administered at 1 gram every 12 hours (q12h) as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
Other Name: Vancocin
6 mg/kg; used only at UK sites
Other Name: Targocid
Other Name: Unipen
Other Name: Bactocill
Other Name: Fluclox
- Any Creatine Phosphokinase (CPK) Elevation > 500 Units Per Liter (U/L) [ Time Frame: From the 3rd day of therapy to 1 week post last dose (approximately week 7) ]Number of subjects with CPK >500 U/L between Day 3 and 7 days following the last dose of study medication (Day 7P) as measured by the central laboratory.
- Safety - Notable Laboratory Abnormalities [ Time Frame: From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30) ]Summary of Notable Laboratory Abnormalities - description of the proportion of subjects within each treatment group that had clinical laboratory values outside the reference range.
- Overall Clinical Outcome [ Time Frame: Approximately 6 weeks post last dose (approximately week 12) ]The sponsor determined overall clinical outcome based on blinded review of clinical, microbiological, and radiological response of the subject including, but not limited to, clinical signs and symptoms of PJI, microbiological assessments, radiographic findings, and surgical procedures performed. Subjects were a success if both clinical and microbiological responses were success. A subject who failed to respond clinically or microbiologically was a failure. If microbiological response was non-evaluable and/or clinical evaluation at TOC was not performed, the subject was non-evaluable.
- Microbiological Response [ Time Frame: Approximately 6 weeks post last dose (approximately week 12) ]Sponsor's assessment of subject-level microbiological response at the test-of-cure visit for the modified Intent-to-Treat (mITT) population.
- Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) [ Time Frame: Day 4 (steady state) ]The pharmacokinetic (PK) parameters of daptomycin at steady state for the 6 mg/kg and 8 mg/kg dose groups. On treatment day 4, PK samples for daptomycin levels were to be obtained prior to start of daptomycin infusion (0 hr) and at 0.5 hr (end of infusion), 1-1.5 hr, 3-5 hr, 8-12 hr, and 24 hr after the start of daptomycin infusion.
- Pharmacokinetic Parameter: Area Under the Concentration-time Curve During a Dosing Interval at Steady State (AUCss) [ Time Frame: Day 4 (steady state) ]The pharmacokinetic (PK) parameters of daptomycin at steady state for the 6 mg/kg and 8 mg/kg dose groups. On treatment day 4, PK samples for daptomycin levels were to be obtained prior to start of daptomycin infusion (0 hr) and at 0.5 hr (end of infusion), 1-1.5 hr, 3-5 hr, 8-12 hr, and 24 hr after the start of daptomycin infusion.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00428844
Show 26 Study Locations
|Study Director:||Alistair Wheeler, MD||Cubist Pharmaceuticals, 65 Hayden Ave, Lexington, MA 02421, USA|