The study hypothesis is that the addition of Aurograb to standard vancomycin therapy will improve outcome in MRSA infection.
The Primary Objective will be to determine whether the overall response (clinical and bacterial) to Aurograb® (1mg/kg i.v. b.d.) plus vancomycin is greater than the overall response to placebo plus vancomycin, in adult hospitalised patients with severe, deep-seated staphylococcal infections, particularly MRSA infections, being treated with vancomycin. Secondary Objectives will be: 1. To further determine efficacy, comparing Aurograb versus placebo, regarding: * attributable mortality * overall mortality * clinical response * bacterial response ie eradication or persistence of the infection * rates of clinical resistance to vancomycin. 2. To compare the safety profile of treatment with Aurograb® (1mg/kg b.d.) plus vancomycin versus placebo plus vancomycin in adult hospitalised patients with deep-seated staphylococcal infections. 3. To extend the data base on pharmacokinetics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
ECT
Masking
DOUBLE
Enrollment
180
Mark Wilcox
Leeds, England, United Kingdom
The response to Aurograb® (1mg/kg i.v. b.d.) plus vancomycin is greater than the overall response to placebo plus vancomycin,in patients with severe, deep-seated staphylococcal infections.
attributable mortality
overall mortality
clinical response
bacterial response
rates of clinical resistance to vancomycin.
To extend the data base on pharmacokinetics.
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