Clinical trial of safety and efficacy of INH-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.


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.
DeJonge
Mitchell
M
DeVos Children's Hospital, Grand Rapids, Michigan, USA.
Burchfield
David
D
Bloom
Barry
B
Duenas
Maria
M
Walker
Whit
W
Polak
Mark
M
Jung
Elizabeth
E
Millard
Dietra
D
Schelonka
Robert
R
Eyal
Fabien
F
Morris
Amy
A
Kapik
Barry
B
Roberson
Destrey
D
Kesler
Karen
K
Patti
Joe
J
Hetherington
Seth
S
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
D016756:Immunoglobulins, Intravenous; D007155:Immunologic Factors; C511124:Veronate