Staphylococcal anti-adhesive antibodies fail to protect premature infants from bloodstream infection (BSI)

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Very low birth weight (≤ 1500 g VLBW) infants comprise 1.4% of births in the United States, and survival rates are increasing. So too, are complications of neonatal intensive care such as late onset septicemia, which occurs in 16 to 25% of VLBW infants. DeJonge et al in this issue of The Journal report the results of a phase III, randomized, double-blind, placebo-controlled multicenter trial of prophylactic use of immunoglobulin selected for high titers of staphylococcal anti-adhesive antibodies (IHN-A21) and prepared for intravenous use (IGIV). The phase III trial was conducted on the heels of a phase II trial that showed a trend toward protection from staphylococcal and candidal bloodstream infection (BSI), with adequate sample size and power in the Phase III trial. Almost 2000 neonates in 95 centers in the United States and Canada received at least one infusion of study drug (750 mg/kg IHN-A21 or saline placebo). Although there was no safety issue, there was no effect on rate or timing of staphylococcal or other BSIs.

In the accompanying editorial, de la Morena puts this definitively negative study result in the context of other disappointments of transiently promising interventions, and speculates on what premature neonates really need.

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