Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Methicillin-Resistant Staphylococcus Aureus and/or Coagulase-Negative Staphylococci - Full Text View

Purpose

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 methicillin-resistant Staphylococcus aureus (MRSA) or coagulase-negative staphylococci (CoNS). These two types of bacteria are among the most common types of bacteria causing infections of prosthetic joints.

Condition	Intervention	Phase
Osteomyelitis	Drug: daptomycin Drug: vancomycin	Phase II

ChemIDplus related topics:

Vancomycin Daptomycin Vancomycin hydrochloride Methicillin Methicillin sodium Teicoplanin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Phase 2 Randomized Study Investigating the Safety, Efficacy and Pharmacokinetics of Daptomycin 6 mg/kg and 8 mg/kg Versus Comparator (Vancomycin or Teicoplanin) in the Treatment of Subjects Undergoing Surgical Standard of Care for Osteomyelitis Associated With an Infected Prosthetic Hip or Knee Joint Caused by Methicillin-Resistant Staphylococcus Aureus and/or Coagulase-Negative Staphylococci

Further study details as provided by Cubist Pharmaceuticals:

Primary Outcome Measures:

Incidence of elevated CPK (defined as any CPK value above 500 U/L based on central laboratory assessments) [ Time Frame: 5 to 7 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

General safety (AEs and SAEs, laboratory analytes, vital signs, concomitant medications and physical examination findings) and efficacy (clinical response, microbiological response, and overall therapeutic response and clinical relapse) [ Time Frame: 5 to 7 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	72
Study Start Date:	January 2007
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Daptomycin 6 mg/kg	Drug: daptomycin 6 mg/kg
2: Experimental Daptomycin 8 mg/kg	Drug: daptomycin 8 mg/kg
3: Active Comparator vancomycin 1 gm	Drug: vancomycin 1 gm

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 infected following implantation of the prosthetic joint and, for which they are anticipated to undergo a two-stage replacement surgery
Subject must have a positive MRSA or CoNS culture or blood culture.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428844

Contacts


Contact: Marie Hippolyte	781-860-8122	marie.hippolyte@cubist.com

Show 22 Study Locations

Sponsors and Collaborators

Cubist Pharmaceuticals

Investigators


Principal Investigator:	Margarita Cancio, MD	Infectious Disease Association of Tampa Bay

More Information

Responsible Party:	Cubist Pharmaceuticals ( Marie Hippolyte, Senior Clinical Trial Manager )
Study ID Numbers:	DAP-OST-06-02
First Received:	January 26, 2007
Last Updated:	August 6, 2008
ClinicalTrials.gov Identifier:	NCT00428844
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cubist Pharmaceuticals:

Osteomyelitis

Prosthetic Hip

Prosthetic Knee

MRSA

Osteomyelitis Associated with an Infected Prosthetic Hip or Knee Joint

Study placed in the following topic categories:

Coagulase

Daptomycin

Teicoplanin

Methicillin

Musculoskeletal Diseases

Vancomycin

Bone Diseases

Osteomyelitis

Additional relevant MeSH terms:

Anti-Infective Agents

Anti-Bacterial Agents

Therapeutic Uses

Infection

Pharmacologic Actions

Bone Diseases, Infectious

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Cubist Pharmaceuticals
Information provided by:	Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00428844