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.
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, hip or shoulder arthroplasty and are at risk for infection
with methicillin resistant Staphylococcus aureus. The study population will include males
and non-pregnant, non-lactating females 18 years of age or older, with history of
methicillin-resistant Staphylococcus aureus infection or colonization, and undergoing
primary elective hip, knee or shoulder arthroplasty. The target enrollment is 100 patients,
who will be randomized to daptomycin or vancomycin in two 50 patient study groups. After
signing the informed consent, patients will undergo pre-enrollment nasal screening for
methicillin resistant Staphylococcus aureus to identify eligible patients. Patients with
positive MRSA nasal screen will proceed with enrollment and get randomized into one of the
two study groups. In one group, patients will receive one dose of daptomycin 6 mg/kg to be
infused over 30 minutes. In this group, the infusion should be started and completed within
60 minutes of surgical incision. In the second group, patients will receive one dose of
vancomycin 15 mg/kg to be infused over 1-2 hours of surgical incision according to the dose
to avoid red man syndrome. In this group, the infusion should be started and completed
within 120 minutes of surgical incision. After surgery, a second similar dose of vancomycin
will be given 12 hours after the first dose to patients with creatinine clearance (CLcr.) of
≥50 ml/min. All patients in both groups will be asked to shower with chlorhexidine skin
cleanser (HIBICLENS®) once daily from the neck down for 7days before surgery and apply
Mupirocin ointment 2% to their nostrils twice daily for 5 days before surgery.
The patients will be evaluated on the day of surgery, at 2-3 days postoperatively, on
discharge, at one month and three months follow up visits. During these study evaluations,
patients will be assessed clinically for signs and symptoms of wound, and prosthetic joint
infection (including pain, tenderness, swelling, erythema, poor wound healing and wound
drainage) prior to hospital discharge, and at one, and three months follow up visits. Blood
work including complete blood counts, erythrocytic sedimentation rate, c-reactive protein,
and cultures will be ordered if clinical findings suggest infection. Bacterial isolates
causing infections will be tested locally for antibiotic susceptibilities including
daptomycin and vancomycin and saved for further testing if needed. Adverse effects and
tolerability will be documented with the use of both drugs in the two patient groups. Data
will be collected and analyzed with appropriate testing. The primary endpoint will be the
success in prevention of postoperative SSI and prosthetic joint infection at one month
postoperative follow up visit.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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