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

• Status: Terminated
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mountain Home Research & Education Corporation
• Collaborators: Cubist Pharmaceuticals LLC; East Tennessee State University
• Treatments: Anti-Infective Agents; Daptomycin; Vancomycin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.