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

Condition(s) targeted: Osteomyelitis

Intervention: daptomycin (Drug); daptomycin (Drug); vancomycin (Drug); teicoplanin (Drug); nafcillin (Drug); oxacillin (Drug); flucloxacillin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Cubist Pharmaceuticals Holdings LLC

Official(s) and/or principal investigator(s):
Alistair Wheeler, MD, Study Director, Affiliation: Cubist Pharmaceuticals, 65 Hayden Ave, Lexington, MA 02421, USA

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.

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Any Creatine Phosphokinase (CPK) Elevation > 500 Units Per Liter (U/L)

Secondary outcome:

Safety - Notable Laboratory Abnormalities

Overall Clinical Outcome

Microbiological Response

Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax)

Pharmacokinetic Parameter: Area Under the Concentration-time Curve During a Dosing Interval at Steady State (AUCss)

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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.

Federal National Institution of Science "Russian Ilizarov Scientific Center" "Restorative Traumatology and Orthopedics" of Rosmedtechnology, Kurgan 640014, Russian Federation

National Healthcare Institution of Moscow "City Clinical Hospital #64", Moscow 117292, Russian Federation

Federal Healthcare Institute "Novosibirsk Scientific Research Institute of Traumatology and Orthopedy Rosmeditechnology", Novosibirsk 630091, Russian Federation

National Educational Institution of Higher Professional Education "Saint Petersburg State Medical Academy n.a. Mechnikov of Roszdrav", Saint Petersburg 195067, Russian Federation

Russian Research Institute of Traumatology and Orthopedy, Saint Petersburg 197046, Russian Federation

National Healthcare Institution "Samara Regional Clinical Hospital n.a. Kalinin", Samara 443095, Russian Federation

UAMS College of Medicine, Little Rock, Arkansas 72205-7199, United States

South Denver Infectious Disease Associates, PC, Englewood, Colorado 80133, United States

Kane and Davis Associates, Washington, District of Columbia 20016, United States

Infectious Disease Association of Tampa Bay, Tampa, Florida 33606, United States

Idaho Falls Infectious Diseases, PLLC, Idaho Falls, Idaho 83404, United States

Rush St. Luke's Medical Center, Chicago, Illinois 60612, United States

Southern Illinois University School of Medicine, Springfield, Illinois 62794, United States

Mayo Clinic, Rochester, Minnesota 55905, United States

Sierra Infectious Disease, Reno, Nevada 89502, United States

Dartmouth-Hitchcock Medical center, Lebanon, New Hampshire 03756, United States

Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States

Summa Health Systems, Akron, Ohio 44304, United States

Cleveland Clinic, Cleveland, Ohio 44195, United States

Regional Infectious Diseases-Infusion Center, Lima, Ohio 45801, United States

Nuffield Orthopaedics Centre, Bone Infection Unit, Headington, Oxford, Oxfordshire OX37LD, United Kingdom

Lehigh Valley Hospital Trauma and Critical Care Research, Allentown, Pennsylvania 18103, United States

Rothman Institute, Philadelphia, Pennsylvania 19107, United States

The Royal Infirmary of Edinburgh at Little France, Edinburgh, Scotland EH164SA, United Kingdom

Brownlee Centre - Gartnavel General Hospital, Glasgow, Scotland G120YN, United Kingdom

Gundersen Clinic, LTD, La Crosse, Wisconsin 54601, United States

Starting date: January 2007
Last updated: July 21, 2015