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



Status:Completed
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - 80
Updated:2/2/2018
Start Date:June 26, 2007
End Date:June 23, 2010

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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

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.


Inclusion Criteria:

- 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 Criteria:

- 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.
We found this trial at
18
sites
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
2515
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Lebanon, NH
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
2035
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from 91732
Cleveland, OH
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Akron, Ohio 44304
2041
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Akron, OH
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2355
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Allentown, PA
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Chicago, Illinois 60612
1726
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Chicago, IL
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805
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Englewood, CO
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Idaho Falls, Idaho 83404
721
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Idaho Falls, ID
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La Crosse, Wisconsin 54601
1579
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La Crosse, WI
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1904
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Lima, OH
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Little Rock, Arkansas 72205
1459
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Little Rock, AR
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Philadelphia, Pennsylvania 19107
2375
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Philadelphia, PA
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Reno, Nevada 89502
385
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Reno, NV
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Rochester, Minnesota 55905
1524
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Rochester, MN
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801 N Rutledge St
Springfield, Illinois 62702
(217) 545-8000
Southern Illinois University School of Medicine At SIU School of Medicine, research includes biologically oriented...
1608
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Springfield, IL
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2137
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Tampa, FL
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Washington, District of Columbia 20016
2278
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Washington,
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
2129
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Winston-Salem, NC
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