Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113191
Status:
COMPLETED
Last Update Posted:
2012-08-02
First Post:
2005-06-06
Brief Title:
Safety and Efficacy of Veronate Versus Placebo in Preventing Nosocomial Staphylococcal Sepsis in Premature Infants
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
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
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None