Clinical trial of safety and efficacy of IHN-A21 for the prevention of nosocomial staphylococcal bloodstream infection in premature infants

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 (Veronatee((R))) 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.