by Muscedere, John;
Maslove, David M.; Boyd, J. Gordon; O’Callaghan, Nicole; Sibley, Stephanie;
Reynolds, Steven; Albert, Martin; Hall, Richard; Jiang, Xuran; Day, Andrew G.;
Jones, Gwyneth; Lamontagne, Francois
Objective: To obtain preliminary evidence for the efficacy of
lactoferrin as a preventative measure for nosocomial infections and inform the
conduct of a definitive study.
Design: Phase 2, multicenter, randomized,
double-blind, placebo-controlled study. Setting: Medical-surgical ICUs.
Patients: Adult, critically ill patients receiving invasive mechanical
ventilation. Interventions: Randomized, 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 Results: Of 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.
Conclusions: Lactoferrin 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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