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

Completed · Phase 2

Conditions studied: Osteomyelitis

In brief

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.

Key facts

Study ID

NCT00428844

Run by

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

People needed

75

Starts

2007-06-26

Expected to finish

2010-06-23

Last updated by the study team

2018-01-31

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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