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Daptomycin Use for Antimicrobial Prophylaxis in Methicillin Resistant Staphylococcus Aureus (MRSA) Colonized Adult Patients Undergoing Primary Elective Hip, Knee, or Shoulder Arthroplasty

NCT01196169 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2014-02-03

No results posted yet for this study

Summary

This study will evaluate the safety and effectiveness of daptomycin, an antibiotic compared to another one which is vancomycin when given around the time of joint replacement surgery. Vancomycin is recommended for perioperative prophylaxis in methicillin resistant Staphylococcus aureus (MRSA) colonized patients undergoing primary total joint arthroplasty. Daptomycin has not been recommended for this indication but it is FDA approved for treatment of MRSA blood stream and skin and soft tissue infections. Data collected during this study may support the use of daptomycin for this indication and may also be used for other research purposes that have not yet been specified.

Conditions

  • Staphylococcal Infections
  • Methicillin-resistant Staphylococcus Aureus

Interventions

DRUG

Daptomycin

One dose of Daptomycin 6 mg/Kg iv, will be infused over 30 minutes. The infusion will start no longer than one hour prior to surgical incision of primary knee or hip prosthetic joint arthroplasty.

DRUG

Vancomycin

Two doses of vancomycin 15 mg/Kg iv, with a maximum of 2 grams with each dose be infused over 60-120 minutes according to the dose. The first dose infusion will start no longer than one hour (if ≤ one gram), or no longer than two hours (if \> one gram) prior to surgical incision of primary knee or hip prosthetic joint arthroplasty. A second similar dose will be given 12 hours after the first dose unless the patient has a creatinine clearance of \< 50 ml/min. Patients with creatinine clearance of \< 50 ml/min will only receive one dose.

Sponsors & Collaborators

  • East Tennessee State University

    collaborator OTHER

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

    collaborator INDUSTRY

  • Mountain Home Research & Education Corporation

    lead OTHER

Principal Investigators

  • Wael E Shams, M.D. · James H Quillen VA Medical Center and East Tennessee State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01196169 on ClinicalTrials.gov