Study will evaluate the safety and potential benefit of talactoferrin (recombinant human lactoferrin) as an addition to the standard care for severe sepsis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,280
15 mL of an oral solution of 100mg/mL (1.5 g) given 3 times a day for up to 28 days or until discharge from the intensive care unit
15 mL of oral solution of placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit
All Cause Mortality
Time frame: 28 Days
All Cause Mortality
Time frame: 3 months
All Cause Mortality
Time frame: 6 months
All Cause Mortality
Time frame: 12 months
Assess Safety and Tolerability
Time frame: 28 days
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