TY - JOUR
T1 - Clinical Trial of Safety and Efficacy of IHN-A21 for the Prevention of Nosocomial Staphylococcal Bloodstream Infection in Premature Infants
AU - DeJonge, Mitchell
AU - Burchfield, David
AU - Bloom, Barry
AU - Duenas, Maria
AU - Walker, Whit
AU - Polak, Mark
AU - Jung, Elizabeth
AU - Millard, Dietra
AU - Schelonka, Robert
AU - Eyal, Fabien
AU - Morris, Amy
AU - Kapik, Barry
AU - Roberson, Destrey
AU - Kesler, Karen
AU - Patti, Joe
AU - Hetherington, Seth
N1 - Funding Information:
The study was funded in its entirety by Inhibitex, Inc. A. Morris, B. Kapik, D. Roberson, J. Patti, and S. Hetherington were all employees of Inhibitex during the course of the study.
PY - 2007/9
Y1 - 2007/9
N2 - 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.
AB - 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.
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U2 - 10.1016/j.jpeds.2007.04.060
DO - 10.1016/j.jpeds.2007.04.060
M3 - Article
C2 - 17719934
AN - SCOPUS:34548048636
SN - 0022-3476
VL - 151
SP - 260-265.e1
JO - Journal of Pediatrics
JF - Journal of Pediatrics
IS - 3
ER -