Status:
TERMINATED
Daptomycin Use for Antimicrobial Prophylaxis in Methicillin Resistant Staphylococcus Aureus (MRSA) Colonized Adult Patients Undergoing Primary Elective Hip, Knee, or Shoulder Arthroplasty
Lead Sponsor:
Mountain Home Research & Education Corporation
Collaborating Sponsors:
East Tennessee State University
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Staphylococcal Infections
Methicillin-resistant Staphylococcus Aureus
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief 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 re...
Detailed Description
This is a phase 4 randomized open label prospective pilot study comparing the use of daptomycin versus vancomycin for peri-operative antibiotic prophylaxis in patients undergoing elective primary knee...
Eligibility Criteria
Inclusion
- Signed, and dated informed consent as defined by the Institutional Review Board.
- Male and female patients older than 18 years of age undergoing primary elective hip, knee or shoulder arthroplasty.
- Documented nasal carriage of MRSA.
- If a female of childbearing potential the patient should agree to practice a reliable contraceptive method (e.g. birth control pills, condoms, or intrauterine device \[IUD\]) during treatment and for one month after receiving the study medication.
Exclusion
- Concurrent urinary tract infection or colonization unless treated with evidence of microbiologic cure.
- Evidence of active infection elsewhere other than urinary tract, unless treated with evidence of microbiologic cure documented by the infectious diseases service.
- Patients undergoing elective secondary arthroplasty.
- Concurrent open wounds
- Pregnant and nursing women (if patient is still of childbearing potential, a negative serum pregnancy test will be confirmed).
- History of allergy or contraindication to study drugs.
- Weight \>150 kg or \<50kg
- Patients with creatinine clearance (CLcr) \< 30ml/min (calculated using the Cockcroft-Gault equation using ideal body weight)
- Severe neutropenia (absolute neutrophil count \<0.500x103 /µl).
- Patients considered unlikely to comply with study procedures or to return for the scheduled post treatment evaluation.
- Ongoing antibiotic therapy for active infection that is anticipated to continue until the day of surgery.
- Any other condition that in the opinion of the investigator, would confound or interfere with evaluation of safety or efficacy of the investigational medication, or prevent compliance with the study protocol.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01196169
Start Date
October 1 2010
End Date
March 1 2014
Last Update
February 3 2014
Active Locations (2)
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1
Johnson City Medical Center
Johnson City, Tennessee, United States, 37604
2
James H Quillen VA Medical Center
Mountain Home, Tennessee, United States, 37684