This 3 arm study will compare the efficacy and safety of beta-lactam with that of 'standard care' in patients with complicated skin and skin structure infections requiring hospitalization. Patients will be randomized to receive 1)beta-lactam 750mg iv q8h 2)beta-lactam 1500mg iv q8h or 3)'standard care' \[PRP (nafcillin or flucloxacillin) or vancomycin, plus aztreonam or ciprofloxacin\]. The anticipated time on study treatment is \<3 months and the target sample size is 100-500 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
313
Clinical cure rate.
Time frame: Event driven
Time to clinical cure
Time frame: Event driven
Time to resolution of signs and symptoms of skin or soft tissue infection
Time frame: Event driven
Bacteriological outcome
Time frame: Event driven
Adverse events; laboratory abnormalities
Time frame: Throughout study
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Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Melbourne, Florida, United States
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Miami Beach, Florida, United States
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Detroit, Michigan, United States
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Detroit, Michigan, United States
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Minneapolis, Minnesota, United States
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Winston-Salem, North Carolina, United States
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Buenos Aires, Argentina
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Buenos Aires, Argentina
...and 52 more locations