Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci - NCT00428844-54601 (Clinical Trial 161349)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy161349.aspx
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| City: |
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La Crosse |
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State:
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WI |
| Zip Code: |
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54601 |
| Conditions: |
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Osteomyelitis |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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. |
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| Study is available at: |
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Gundersen Clinic, LTD
La Crosse, WI 54601
United States
Primary Contact:
Ed Campanaro
Email: ed.campanaro@cubist.com
Phone: 781-860-8318 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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