A Phase III, Randomized, Double-blind, Multi-center Clinical Trial Comparing the Safety and Efficacy of Veronate® Versus Placebo for the Prevention of Nosocomial Staphylococcal Sepsis in Premature Infants (Birth Weight 500 - 1250 g)
A Phase III, Randomized, Double-blind, Multi-center Clinical Trial Comparing the Safety and Efficacy of Veronate® Versus Placebo for the Prevention of Nosocomial Staphylococcal Sepsis in Premature Infants (Birth Weight 500 - 1250 g)
The purpose of this study is to show whether Veronate, a donor-selected staphylococcal human immune globulin intravenous (IGIV), can prevent an infection in the blood caused by staphylococcal bacteria in premature babies weighing between 500 and 1250 grams at birth.
Babies are enrolled between Day of Life 3 and 5. Babies are randomized to either Veronate or placebo (50-50 chance of either). Babies can receive up to 4 doses of the study drug on Study Days 1, 3, 8 and 15 and are followed until Study Day 70 or discharge from the hospital.
Inclusion Criteria:
Exclusion Criteria:
Already received or likely to receive prior to first infusion of Study Drug:
Receiving an agent for prevention of staphylococcal catheter related or nosocomial infections (e.g., vancomycin)
Active sepsis, as defined by one of the following:
Severe congenital anomaly, where the prospects for survival, the medical complications and treatment, would compromise the study related outcome evaluation(s) in the Investigator's opinion
Diagnosis of congenital immunodeficiency
Evidence of significant fluid overload or significant volume depletion
Evidence of abnormal renal function as measured by serum creatinine > 1.6 mg/dL