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 weights500 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.
RCT Entities:
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.
Authors: Bao Zhong Zhang; Yan Hong Hua; Bin Yu; Candy Choi Yi Lau; Jian Piao Cai; Song Yue Zheng; Wing Cheong Yam; Richard Yi Tsun Kao; Kong Hung Sze; Bo Jian Zheng; Kwok Yung Yuen; Jian Dong Huang Journal: Infect Immun Date: 2014-11-03 Impact factor: 3.441
Authors: Bruce Y Lee; Paul J Ufberg; Rachel R Bailey; Ann E Wiringa; Kenneth J Smith; Andrew J Nowalk; Conor Higgins; Angela R Wateska; Robert R Muder Journal: Vaccine Date: 2010-05-14 Impact factor: 3.641
Authors: Lorena P N Tuchscherr; Fernanda R Buzzola; Lucía P Alvarez; Jean C Lee; Daniel O Sordelli Journal: Infect Immun Date: 2008-09-22 Impact factor: 3.441
Authors: Santiago M Lattar; Mariángeles Noto Llana; Philippe Denoël; Sophie Germain; Fernanda R Buzzola; Jean C Lee; Daniel O Sordelli Journal: Infect Immun Date: 2013-10-14 Impact factor: 3.441