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J Pediatr. 2007 Sep;151(3):260-5, 265.e1. Epub 2007 Jul 24.

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

Author information

1
DeVos Children's Hospital, Grand Rapids, Michigan, USA.

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.

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00113191.

PMID:
17719934
DOI:
10.1016/j.jpeds.2007.04.060
[Indexed for MEDLINE]

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