A Phase 2 Randomized, Double-Blind, Placebo– Controlled Study of the Safety and Efficacy of Talactoferrin in Patients With Severe Sepsis*,

A Phase 2 Randomized, Double-Blind, Placebo–Controlled Study of the Safety and Efficacy ofTalactoferrin in Patients With Severe Sepsis*

Objectives:
Lactoferrin is a glycoprotein with anti-infective and antiinflammatory
properties found in secretions and immune cells. Talactoferrin
alfa, a recombinant form of human lactoferrin, has similar
properties and plays an important role in maintaining the gastrointestinal
mucosal barrier integrity. In experimental animal models, administration
of talactoferrin reduces translocation of bacteria from the gut
into the systemic circulation and mortality from sepsis. Our objective
was to determine if talactoferrin could reduce 28-day all-cause mortality
in patients with severe sepsis and to assess its safety.