title: Clinical trial of safety and efficacy of INH-A21 for the prevention of nosocomial staphylococcal bloodstream infection in premature infants.
abstract: 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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  INH-A21 failed to reduce the incidence of staphylococcal LOS or candidemia in premature infants.
authors.affiliation: DeVos Children's Hospital, Grand Rapids, Michigan, USA.
authors.forename: Mitchell
authors.initials: M
authors.lastname: DeJonge
authors.forename: David
authors.initials: D
authors.lastname: Burchfield
authors.forename: Barry
authors.initials: B
authors.lastname: Bloom
authors.forename: Maria
authors.initials: M
authors.lastname: Duenas
authors.forename: Whit
authors.initials: W
authors.lastname: Walker
authors.forename: Mark
authors.initials: M
authors.lastname: Polak
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Jung
authors.forename: Dietra
authors.initials: D
authors.lastname: Millard
authors.forename: Robert
authors.initials: R
authors.lastname: Schelonka
authors.forename: Fabien
authors.initials: F
authors.lastname: Eyal
authors.forename: Amy
authors.initials: A
authors.lastname: Morris
authors.forename: Barry
authors.initials: B
authors.lastname: Kapik
authors.forename: Destrey
authors.initials: D
authors.lastname: Roberson
authors.forename: Karen
authors.initials: K
authors.lastname: Kesler
authors.forename: Joe
authors.initials: J
authors.lastname: Patti
authors.forename: Seth
authors.initials: S
authors.lastname: Hetherington
mesh_terms: D017668:Age of Onset; D015897:Comorbidity; D003428:Cross Infection / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use*; D007155:Immunologic Factors / Q000627:therapeutic use*; D007231:Infant, Newborn; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000517:prevention & control*; D019102:Infant, Very Low Birth Weight; D007902:Length of Stay; D008297:Male; D018805:Sepsis / Q000453:epidemiology / Q000382:microbiology* / Q000517:prevention & control*; D013203:Staphylococcal Infections / Q000517:prevention & control*; D013997:Time Factors
chemical_list: D016756:Immunoglobulins, Intravenous; D007155:Immunologic Factors; C511124:Veronate