Staphylococcal Infections Clinical Trial
Official title:
Daptomycin Use For Prophylaxis In Prosthetic Joint Surgery, A Randomized Prospective Study Comparing The Efficacy Of Daptomycin Versus Vancomycin For Peri-Operative Antibiotic Prophylaxis In MRSA Colonized Adult Patients Undergoing Primary Elective Hip, Knee or Shoulder Arthroplasty
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.
Status | Terminated |
Enrollment | 28 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Johnson City Medical Center | Johnson City | Tennessee |
United States | James H Quillen VA Medical Center | Mountain Home | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Mountain Home Research & Education Corporation | Cubist Pharmaceuticals LLC, East Tennessee State University |
United States,
Bratzler DW, Houck PM; Surgical Infection Prevention Guidelines Writers Workgroup; American Academy of Orthopaedic Surgeons; American Association of Critical Care Nurses; American Association of Nurse Anesthetists; American College of Surgeons; American College of Osteopathic Surgeons; American Geriatrics Society; American Society of Anesthesiologists; American Society of Colon and Rectal Surgeons; American Society of Health-System Pharmacists; American Society of PeriAnesthesia Nurses; Ascension Health; Association of periOperative Registered Nurses; Association for Professionals in Infection Control and Epidemiology; Infectious Diseases Society of America; Medical Letter; Premier; Society for Healthcare Epidemiology of America; Society of Thoracic Surgeons; Surgical Infection Society. Antimicrobial prophylaxis for surgery: an advisory statement from the National Surgical Infection Prevention Project. Clin Infect Dis. 2004 Jun 15;38(12):1706-15. Epub 2004 May 26. Review. — View Citation
Lamp KC, Friedrich LV, Mendez-Vigo L, Russo R. Clinical experience with daptomycin for the treatment of patients with osteomyelitis. Am J Med. 2007 Oct;120(10 Suppl 1):S13-20. — View Citation
Marculescu CE, Osmon DR. Antibiotic prophylaxis in orthopedic prosthetic surgery. Infect Dis Clin North Am. 2005 Dec;19(4):931-46. Review. — View Citation
Price CS, Williams A, Philips G, Dayton M, Smith W, Morgan S. Staphylococcus aureus nasal colonization in preoperative orthopaedic outpatients. Clin Orthop Relat Res. 2008 Nov;466(11):2842-7. doi: 10.1007/s11999-008-0337-x. Epub 2008 Jun 19. — View Citation
Zimmerli W, Trampuz A, Ochsner PE. Prosthetic-joint infections. N Engl J Med. 2004 Oct 14;351(16):1645-54. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Daptomycin efficacy in prevention of postoperative surgical site infection (SSI) | Efficacy of daptomycin in preventing postoperative SSI will be determined for each enrolled subject on one month postoperative visit. Overall efficacy of daptomycin among the patient group who receive it will be compared to overall efficacy of vancomycin among the second patient group who receive vancomycin upon anticipated complete enrollment study at 24 months. | 24 months | No |
Secondary | Efficacy of daptomycin in preventing postoperative early prosthetic joint infection | Efficacy of daptomycin in preventing postoperative early prosthetic joint infection will be determined for each enrolled subject on three months postoperative visit. Overall efficacy of daptomycin among the patient group who receive it will be compared to overall efficacy of vancomycin among the second patient group who receive vancomycin upon anticipated completion of the study at 30 months | 30 months | No |
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