A Study of Beta-Lactam in Hospitalized Patients With Skin and Skin Structure Infections
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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.
A Phase II Prospective, Open Label, Randomized, Active-controlled, Parallel Group, Multi-center 'Proof of Concept' Trial in Adult Patients With Complicated Skin or Skin Structure Infections Requiring Hospitalization.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
adult patients, >=18 years of age;
skin or skin structure infection requiring hospitalization;
clinical diagnosis of a skin or skin structure infection caused by bacteria known or suspected to be susceptible to the randomized study treatment;
material from site of infection is clinically purulent or seropurulent.
presenting with sustained shock (SBP<90mm Hg for > 2 hours, despite adequate fluid resuscitation);
known or suspected concomitant bacterial infection requiring antibiotic treatment;
skin infection or chronic non-healing ulcer of > 2 weeks duration;
patients in whom surgery is the primary treatment.