NCT00113191

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,000 (planned)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 3 Days – 5 Days
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Nosocomial Infections
• Sepsis
• Staphylococcal Infections
• Candidemia

Interventions

Type	Name	Description
DRUG	Veronate

Timeline

• Start date: 2004-05-01
• Primary completion: 2006-06-01
• Completion: 2006-06-01
• First posted: 2005-06-07
• Last updated: 2012-08-02

Locations

93 sites across 2 countries: United States, Canada