Clinical trial NCT00428844: Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteomyelitis
Keywords: Osteomyelitis
Prosthetic Hip
Prosthetic Knee
MRSA
Osteomyelitis Associated with an Infected Prosthetic Hip or Knee Joint
Staphylococci
Lead sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2007-01-30
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Any Creatine Phosphokinase (CPK) Elevation > 500 Units Per Liter (U/L)
timeFrame: From the 3rd day of therapy to 1 week post last dose (approximately week 7)
Secondary outcomes:
measure: Safety - Notable Laboratory Abnormalities
timeFrame: From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
measure: Overall Clinical Outcome
timeFrame: Approximately 6 weeks post last dose (approximately week 12)
measure: Microbiological Response
timeFrame: Approximately 6 weeks post last dose (approximately week 12)
measure: Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax)
timeFrame: Day 4 (steady state)
measure: Pharmacokinetic Parameter: Area Under the Concentration-time Curve During a Dosing Interval at Steady State (AUCss)
timeFrame: Day 4 (steady state)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: UAMS College of Medicine
state: Arkansas
city: Englewood
country: United States
facility: South Denver Infectious Disease Associates, PC
state: Colorado
city: Washington
country: United States
facility: Kane and Davis Associates
state: District of Columbia
city: Tampa
country: United States
facility: Infectious Disease Association of Tampa Bay
state: Florida
city: Idaho Falls
country: United States
facility: Idaho Falls Infectious Diseases, PLLC
state: Idaho
city: Chicago
country: United States
facility: Rush St. Luke's Medical Center
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Reno
country: United States
facility: Sierra Infectious Disease
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical center
state: New Hampshire
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Akron
country: United States
facility: Summa Health Systems
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Lima
country: United States
facility: Regional Infectious Diseases-Infusion Center
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Hospital Trauma and Critical Care Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
city: La Crosse
country: United States
facility: Gundersen Clinic, LTD
state: Wisconsin
city: Kurgan
country: Russian Federation
facility: Federal National Institution of Science "Russian Ilizarov Scientific Center" "Restorative Traumatology and Orthopedics" of Rosmedtechnology
city: Moscow
country: Russian Federation
facility: National Healthcare Institution of Moscow "City Clinical Hospital #64"
city: Novosibirsk
country: Russian Federation
facility: Federal Healthcare Institute "Novosibirsk Scientific Research Institute of Traumatology and Orthopedy Rosmeditechnology"
city: Saint Petersburg
country: Russian Federation
facility: National Educational Institution of Higher Professional Education "Saint Petersburg State Medical Academy n.a. Mechnikov of Roszdrav"
city: Saint Petersburg
country: Russian Federation
facility: Russian Research Institute of Traumatology and Orthopedy
city: Samara
country: Russian Federation
facility: National Healthcare Institution "Samara Regional Clinical Hospital n.a. Kalinin"
city: Headington, Oxford
country: United Kingdom
facility: Nuffield Orthopaedics Centre, Bone Infection Unit
state: Oxfordshire
city: Edinburgh
country: United Kingdom
facility: The Royal Infirmary of Edinburgh at Little France
state: Scotland
city: Glasgow
country: United Kingdom
facility: Brownlee Centre - Gartnavel General Hospital
state: Scotland
Study officials:
affiliation: Cubist Pharmaceuticals, 65 Hayden Ave, Lexington, MA 02421, USA
name: Alistair Wheeler, MD
role: STUDY_DIRECTOR
References:
citation: 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.