Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci
Tracking Information
Start Date ICMJE | January 2007 |
---|---|
Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: March 19, 2008) | Incidence of elevated CPK (defined as any CPK value above 500 U/L based on central laboratory assessments) [ Time Frame: 5 to 7 weeks ] [ Designated as safety issue: Yes ] |
Original Primary Outcome Measures ICMJE (submitted: August 16, 2007) | Incidence of elevated CPK (defined as any CPK value above 500 U/L based on central laboratory assessments) [ Time Frame: 5 to 7 weeks ] |
Change History | Complete list of historical versions of study NCT00428844 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: March 19, 2008) | General safety (AEs and SAEs, laboratory analytes, vital signs, concomitant medications and physical examination findings) and efficacy (clinical response, microbiological response, and overall therapeutic response and clinical relapse) [ Time Frame: 5 to 7 weeks ] [ Designated as safety issue: Yes ] |
Original Secondary Outcome Measures ICMJE (submitted: August 16, 2007) | General safety (AEs and SAEs, laboratory analytes, vital signs, concomitant medications and physical examination findings) and efficacy (clinical response, microbiological response, and overall therapeutic response and clinical relapse) [ Time Frame: 5 to 7 weeks ] |
Descriptive Information
Brief Title ICMJE | Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci |
---|---|
Official Title ICMJE | 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 |
Brief 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. |
Detailed Description | |
Study Phase | Phase II |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Osteomyelitis |
Intervention ICMJE |
|
Study Arms / Comparison Groups |
|
Recruitment Information
Recruitment Status ICMJE | Recruiting | ||||
---|---|---|---|---|---|
Estimated Enrollment ICMJE | 72 | ||||
Estimated Completion Date | July 2010 | ||||
Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
Gender | Both | ||||
Ages | 18 Years to 80 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
| ||||
Location Countries ICMJE | United States, Russian Federation, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00428844 | ||||
---|---|---|---|---|---|
Responsible Party | Ed Campanaro, VP ClinOps and Data Mgmt, Cubist Pharmaceuticals | ||||
Study ID Numbers ICMJE | DAP-OST-06-02 | ||||
Study Sponsor ICMJE | Cubist Pharmaceuticals | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
| ||||
Information Provided By | Cubist Pharmaceuticals |
Source: http://clinicaltrials.gov/