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

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. In this double-blind, placebo-controlled study, in...

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Bibliographic Details
Published in:The Journal of pediatrics 2007-09, Vol.151 (3), p.260-265
Main Authors: DeJonge, Mitchell, Burchfield, David, Bloom, Barry, Duenas, Maria, Walker, Whit, Polak, Mark, Jung, Elizabeth, Millard, Dietra, Schelonka, Robert, Eyal, Fabien, Morris, Amy, Kapik, Barry, Roberson, Destrey, Kesler, Karen, Patti, Joe, Hetherington, Seth
Format: Article
Language:English
Subjects:
Age of Onset
Comorbidity
Cross Infection - prevention & control
Double-Blind Method
Female
Humans
Immunoglobulins, Intravenous - therapeutic use
Immunologic Factors - therapeutic use
Infant, Newborn
Infant, Premature
Infant, Premature, Diseases - prevention & control
Infant, Very Low Birth Weight
Length of Stay
Male
Sepsis - epidemiology
Sepsis - microbiology
Sepsis - prevention & control
Staphylococcal Infections - prevention & control
Time Factors
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Summary: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. 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. 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. INH-A21 failed to reduce the incidence of staphylococcal LOS or candidemia in premature infants.
ISSN:1097-6833