This is a study to evaluate the efficacy of Ceftaroline in the treatment of bone and joint infections.
Study evaluates the efficacy of Ceftaroline 600mg IV every 8 hours for the treatment of acute osteomyelitis and/or infected joints.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
The duration of treatment will vary based on type of infection (acute osteomyelitis or joint infection) and if MRSA positive or negative.
Orlando Regional Medical Center
Orlando, Florida, United States
Sustained clinical remission from the treated osteoarticular infection
Sustained clinical remission is defined by the absence of either clinical or microbiological evidence of failure at 1 year after study drug completion, in patients who complete the protocol's antibiotic regimen(s) and did not require subsequent antibiotics for their osteoarticular infection beyond the protocol prescribed regimen.
Time frame: 1 year after study drug completion
Initial clinical success from the treated osteoarticular infection
Initial clinical success will be measured by the agreement of the Infectious disease consultant and Orthopedic surgeon that the patient has had a positive response to therapy. Success will be measured by decrease of CRP (C reactive protein) by 50% from baseline if initially elevated, no evidence of drainage, sinus tract formation or infection related bone instability. Follow up cultures, if available are negative for originally isolated organism. In patients with prothetic joints no new warmth, tenderness or inflammation.
Time frame: 30 days after conclusion of study antibiotic
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