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A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Talactoferrin in Patients with Severe Sepsis
Study Question: Is talactoferrin (TLF) safe and effective in reducing 28-day all-cause mortality in patients with severe sepsis?
Study Description: This was a double-blind, placebo-controlled study of enteral TLF in adult patients with severe sepsis. Participants with sepsis and evidence of acute dysfunction in at least one organ system were randomized to receive either TLF or placebo for up to 28 days or until discharge from the ICU, whichever occurred first. Requirements for inclusion were the ability to take enteral medications and severe sepsis onset within the past 24 hours. All patients received standard care for sepsis, including drotrecogin alfa at the discretion of the primary physician. Safety was monitored daily, and a final safety evaluation was completed 4 weeks after the last dose of study drug. Patients were contacted at 28 days, 3 months, and 6 months post-randomization to determine survival status. The modified intention-to-treat population (MITT) included all patients based on the treatment they received in the first week.
Results: A total of 190 patients were included in the final MITT population (97 patients received TLF and 93 patients received placebo) with similar baseline characteristics between groups. Treatment with TLF decreased mortality from 26.9% (placebo) to 14.4% (TLF) (p = 0.052), representing a 12.5% absolute and a 46.5% relative reduction in mortality. This reduction in all-cause mortality was sustained at 6 months in the overall population (p = 0.039). There were no clinically significant differences in adverse events noted between the treatment groups.
Conclusion(s): Talactoferrin administration reduced 28-day all-cause mortality in patients with severe sepsis.
Perspective: TLF, an investigational drug, offers promise as an additional therapeutic option for severe sepsis that appears to be well tolerated. However, it presently requires enteral administration, which limits its utility in select patients. Further investigation and independent replication of these findings are warranted to truly elucidate the efficacy and safety of TLF.