Clinical Trial of Safety and Efficacy of IHN-A21 for the Prevention of Nosocomial Staphylococcal Bloodstream Infection in Premature Infants

Mitchell DeJonge, David Burchfield, Barry Bloom, Maria Duenas, Whit Walker, Mark Polak, Elizabeth Jung, Dietra Millard, Robert Schelonka, Fabien Eyal, Amy Morris, Barry Kapik, Destrey Roberson, Karen Kesler, Joe Patti, Seth Hetherington

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113 Scopus citations

Abstract

Objective: To determine if INH-A21, an intravenous immune globulin (IGIV) derived from donors with high titers of antibody to surface adhesins of Staphylococcus epidermidis and S aureus prevents late-onset sepsis (LOS) in very low birth weight (VLBW) infants. Study design: In this double-blind, placebo-controlled study, infants with birth weights 500 to 1250 g were randomized to receive up to four doses of INH-A21 (Veronate®) or placebo. The primary objective was to determine the safety and efficacy of INH-A21 versus placebo for prevention of S aureus LOS in VLBW infants. Results: A total of 1983 infants from 95 neonatal intensive care units were randomized, and received at least one dose of study drug. S aureus LOS developed in 50 of 989 (5%) and 60 of 994 (6%) infants who received placebo or INH-A21, respectively (P = .34). No differences were found in the frequencies of LOS caused by coagulase-negative staphylococci (CoNS), Candida spp, or overall mortality. No adverse events were statistically significantly associated with INH-A21 infusions compared with placebo. Conclusion: INH-A21 failed to reduce the incidence of staphylococcal LOS or candidemia in premature infants.

Original languageEnglish (US)
Pages (from-to)260-265.e1
JournalJournal of Pediatrics
Volume151
Issue number3
DOIs
StatePublished - Sep 2007

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ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

DeJonge, M., Burchfield, D., Bloom, B., Duenas, M., Walker, W., Polak, M., Jung, E., Millard, D., Schelonka, R., Eyal, F., Morris, A., Kapik, B., Roberson, D., Kesler, K., Patti, J., & Hetherington, S. (2007). Clinical Trial of Safety and Efficacy of IHN-A21 for the Prevention of Nosocomial Staphylococcal Bloodstream Infection in Premature Infants. Journal of Pediatrics, 151(3), 260-265.e1. https://doi.org/10.1016/j.jpeds.2007.04.060