Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci
NCT ID: NCT00428844
Last Updated: 2018-01-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
75 participants
INTERVENTIONAL
2007-06-26
2010-06-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Daptomycin 6 mg/kg
Daptomycin (6 mg/kg every 24 hours \[q24h\]) as a 30 minute intravenous (IV) infusion for 6 weeks (± one week).
daptomycin
6 mg/kg
Daptomycin 8 mg/kg
Daptomycin (8 mg/kg q24h) as a 30 minute IV infusion for 6 weeks (± one week).
daptomycin
8 mg/kg
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).
vancomycin
1 gram
teicoplanin
6 mg/kg; used only at UK sites
nafcillin
1-2 gram
oxacillin
1-2 gram
flucloxacillin
1-2 mg
Interventions
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daptomycin
6 mg/kg
daptomycin
8 mg/kg
vancomycin
1 gram
teicoplanin
6 mg/kg; used only at UK sites
nafcillin
1-2 gram
oxacillin
1-2 gram
flucloxacillin
1-2 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
80 Years
ALL
No
Sponsors
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Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
INDUSTRY
Responsible Party
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Principal Investigators
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Alistair Wheeler, MD
Role: STUDY_DIRECTOR
Cubist Pharmaceuticals, 65 Hayden Ave, Lexington, MA 02421, USA
Locations
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UAMS College of Medicine
Little Rock, Arkansas, United States
South Denver Infectious Disease Associates, PC
Englewood, Colorado, United States
Kane and Davis Associates
Washington D.C., District of Columbia, United States
Infectious Disease Association of Tampa Bay
Tampa, Florida, United States
Idaho Falls Infectious Diseases, PLLC
Idaho Falls, Idaho, United States
Rush St. Luke's Medical Center
Chicago, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Mayo Clinic
Rochester, Minnesota, United States
Sierra Infectious Disease
Reno, Nevada, United States
Dartmouth-Hitchcock Medical center
Lebanon, New Hampshire, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Summa Health Systems
Akron, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Regional Infectious Diseases-Infusion Center
Lima, Ohio, United States
Lehigh Valley Hospital Trauma and Critical Care Research
Allentown, Pennsylvania, United States
Rothman Institute
Philadelphia, Pennsylvania, United States
Gundersen Clinic, LTD
La Crosse, Wisconsin, United States
Federal National Institution of Science "Russian Ilizarov Scientific Center" "Restorative Traumatology and Orthopedics" of Rosmedtechnology
Kurgan, , Russia
National Healthcare Institution of Moscow "City Clinical Hospital #64"
Moscow, , Russia
Federal Healthcare Institute "Novosibirsk Scientific Research Institute of Traumatology and Orthopedy Rosmeditechnology"
Novosibirsk, , Russia
National Educational Institution of Higher Professional Education "Saint Petersburg State Medical Academy n.a. Mechnikov of Roszdrav"
Saint Petersburg, , Russia
Russian Research Institute of Traumatology and Orthopedy
Saint Petersburg, , Russia
National Healthcare Institution "Samara Regional Clinical Hospital n.a. Kalinin"
Samara, , Russia
Nuffield Orthopaedics Centre, Bone Infection Unit
Headington, Oxford, Oxfordshire, United Kingdom
The Royal Infirmary of Edinburgh at Little France
Edinburgh, Scotland, United Kingdom
Brownlee Centre - Gartnavel General Hospital
Glasgow, Scotland, United Kingdom
Countries
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References
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Byren I, Rege S, Campanaro E, Yankelev S, Anastasiou D, Kuropatkin G, Evans R. Randomized controlled trial of the safety and efficacy of Daptomycin versus standard-of-care therapy for management of patients with osteomyelitis associated with prosthetic devices undergoing two-stage revision arthroplasty. Antimicrob Agents Chemother. 2012 Nov;56(11):5626-32. doi: 10.1128/AAC.00038-12. Epub 2012 Aug 20.
Other Identifiers
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DAP-OST-06-02
Identifier Type: OTHER
Identifier Source: secondary_id
3009-016
Identifier Type: -
Identifier Source: org_study_id
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