Status:
COMPLETED
Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci
Lead Sponsor:
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Osteomyelitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 Staph...
Eligibility Criteria
Inclusion
- Subject must be between the ages of 18 and 80, inclusive
- Subject must have a diagnosis of prosthetic joint infection (PJI) in a hip or knee joint which has never previously been totally revised because of an infection and for which they are anticipated to undergo a two-stage replacement surgery
- Subject must have a positive microbiological identifier of staphylococci.
- If Subject is female of childbearing potential, must be willing to practice reliable birth control
Exclusion
- Subject has permanent intravascular prosthetic material such as heart valves or pacemakers
- Subject has a creatinine clearance (CLCR) \<30 mL/min as determined by the Cockcroft-Gault equation using actual body weight.
- Subject has significant hepatic dysfunction
- Subject has a fungal or mycobacterial PJI
- Subject is known to be HIV-infected with CD4 count ≤ 200 cells/ mm3
- Subject has an abnormal creatine phosphokinase (CPK) (elevated CPK level ≥ 2x ULN) at baseline as measured by central laboratory
- Subject is currently under treatment with chemotherapeutic agents excluding chronic maintenance therapy (e.g. tamoxifen to prevent relapse of primary breast cancer)
- Subject is pregnant, nursing, or lactating.
- Subject is receiving or is expected to receive chronic immunosuppressive therapy during the study.
Key Trial Info
Start Date :
June 26 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 23 2010
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00428844
Start Date
June 26 2007
End Date
June 23 2010
Last Update
January 31 2018
Active Locations (26)
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1
UAMS College of Medicine
Little Rock, Arkansas, United States, 72205-7199
2
South Denver Infectious Disease Associates, PC
Englewood, Colorado, United States, 80133
3
Kane and Davis Associates
Washington D.C., District of Columbia, United States, 20016
4
Infectious Disease Association of Tampa Bay
Tampa, Florida, United States, 33606