• John Muscedere, David M Maslove, J Gordon Boyd, Nicole O'Callaghan, Stephanie Sibley, Steven Reynolds, Martin Albert, Richard Hall, Xuran Jiang, Andrew G Day, Gwyneth Jones, and Francois Lamontagne.
• Department of Critical Care Medicine, Queen's University, Kingston, ON, Canada.
• Crit. Care Med. 2018 Sep 1; 46 (9): 1450-1456.

ObjectiveTo obtain preliminary evidence for the efficacy of lactoferrin as a preventative measure for nosocomial infections and inform the conduct of a definitive study.DesignPhase 2, multicenter, randomized, double-blind, placebo-controlled study.SettingMedical-surgical ICUs.PatientsAdult, critically ill patients receiving invasive mechanical ventilation.InterventionsRandomized, eligible, consenting patients expected to require invasive mechanical ventilation more than 48 hours received lactoferrin both enterally and via an oral swab or a placebo of sterile water for up to 28 days.Measurements And Main ResultsOf the 214 patients who were randomized, 212 received at least one dose of the intervention and were analyzed (107 lactoferrin and 105 placebo). Protocol adherence was 87.5%. Patients receiving lactoferrin were older (mean [SD], 66.3 [13.5] vs 62.5 [16.2] yr), had a higher Acute Physiology and Chronic Health Evaluation II score (26.8 [7.8] vs 23.5 [7.9]), and need for vasopressors (79% vs 70%). Antibiotic-free days (17.3 [9.0] vs 18.5 [7.1]; p = 0.91) and nosocomial infections (0.3 [0.7] vs 0.4 [0.6] per patient; p = 0.48) did not differ between lactoferrin and placebo groups, respectively. Clinical outcomes for lactoferrin versus placebo were as follows: ICU length of stay (14.5 [18.0] vs 15.0 [37.3] d; p = 0.82), hospital length of stay (25.0 [25.9] vs 28.1 [44.6] d; p = 0.57), hospital mortality (41.1% vs 30.5%; p = 0.11), and 90-day mortality (44.9% vs 32.4%; p = 0.06). Biomarker levels did not differ between the groups.ConclusionsLactoferrin did not improve the primary outcome of antibiotic-free days, nor any of the secondary outcomes. Our data do not support the conduct of a larger phase 3 trial.

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