Clinical and Economic Outcomes of Ceftaroline Fosamil for ABSSSI Documented or at Risk of MRSA
Status:
Completed
Trial end date:
2016-05-01
Target enrollment:
Participant gender:
Summary
The proposed study is a prospective, open-label, randomized, multi-center trial of
ceftaroline versus vancomycin for the treatment of ABSSSI in patients documented or at risk
for MRSA. Patients admitted to the Detroit Medical Center, Henry Ford Hospital, or St. John
Medical Center in Detroit Michigan with a documented ABSSSI between April 2012 and November
2015 will be evaluated for inclusion. Patients must present with at least 3 of the following
local signs/symptoms: pain, tenderness, swelling erythema, warmth, drainage/discharge,
induration, and lymph node swelling/tenderness. Patients will be randomized 1:1 ceftaroline
or vancomycin with optional anaerobic and/or Gram-negative coverage. The assignment of study
drug will follow a randomized list that was previously generated via a computerized random
mix block generator (nQuery Advisor® 7.0) and available at each of the study sites. Patients
will be randomized to ceftaroline intravenously at 600 mg infused over 1 hour every 12 hours
for patients with normal renal function. Patients randomized to vancomycin will receive the
standard 15 mg/kg dose based on total body weight infused over 1 hour q 12 hour, dose and
interval adjusted based on creatinine clearance and via institution-specific pharmacy
protocol to target serum trough concentrations of 10-20 mg/L within the first 72 hours.
Outcomes measured in the Clinically Evaluable patient population include day two or three
size reduction (percentage) and clinical response at end of therapy or discharge.
Phase:
Phase 4
Details
Lead Sponsor:
Wayne State University
Collaborators:
Detroit Medical Center Forest Laboratories Henry Ford Hospital St. John Providence Health System