This is a study of safety and efficacy of ceftaroline fosamil in Subjects with Staphylococcus aureus Bacteremia or with Methicillin-Resistant Staphylococcus aureus (MRSA) Bacteremia persisting after at least 72 hours of vancomycin and/or daptomycin treatment.
Subjects with either S. aureus bacteremia or persistent MRSA bacteremia will be treated with open label ceftaroline fosamil, safety will be monitored and clearance of bacteremia will be evaluated.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Ceftaroline fosamil 600 mg intravenous (IV) infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour) (dosing may be adjusted for renal function)
Investigational Site
Evaluate the safety of ceftaroline fosamil in adult Subjects (≥ 18 years of age) with Staphylococcus aureus Bacteremia or with MRSA Bacteremia persisting after at least 72 hours of vancomycin and/or daptomycin treatment
Efficacy outcome measures: * Time to clearance of bacteremia * Time to defervescence * Clinical outcome * Mortality * Readmission
Time frame: 60 days following completion of antibacterial therapy and discharge from the hospital, anticipated between 74 to 119 days
Evaluate the efficacy of ceftaroline fosamil in adult Subjects (≥ 18 years of age) with Staphylococcus aureus Bacteremia or with MRSA Bacteremia persisting after at least 72 hours of vancomycin and/or daptomycin treatment
Safety evaluations will be conducted and assessments will include: * Adverse events including deaths will be evaluated * Laboratory: complete blood count (CBC) with differential and chemistry panel
Time frame: Between 3 and 119 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Birmingham, Alabama, United States
Investigational Site
Sacramento, California, United States
Investigational Site
San Francisco, California, United States
Investigational Site
Sylmar, California, United States
Investigational Site
Torrance, California, United States
Investigational Site
Hartford, Connecticut, United States
Investigational Site
Pensacola, Florida, United States
Investigational Site
Stuart, Florida, United States
Investigational Site
Decatur, Georgia, United States
Investigational Site
Macon, Georgia, United States
...and 17 more locations