Safety and Efficacy of Veronate® Versus Placebo in Preventing Nosocomial Staphylococcal Sepsis in Premature Infants
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)
Lead SponsorBristol-Myers Squibb
StatusCompleted No Results Posted
Indication/ConditionNosocomial Infections Sepsis Candidemia Staphylococcal Infections
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: Written informed consent obtained from parent or legal guardian Birth weight 500 to 1250 g, inclusive Age 3 - 5 days (49 to 120 hours), inclusive Expected to require IV access for medical care through day of life 14 Exclusion Criteria: Already received or likely to receive prior to first infusion of Study Drug: IGIV or *immune globulin for prevention of Hepatitis B Receiving an agent for prevention of staphylococcal catheter related or nosocomial infections (e.g., vancomycin) Active sepsis, as defined by one of the following: culture proven early onset sepsis and not clinically stable; or clinical signs of sepsis and pending blood cultures; if the blood cultures are negative after 48 hours and the infant is clinically stable, the infant may be randomized 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