Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066989
Status:
COMPLETED
Last Update Posted:
2012-05-14
First Post:
2003-08-08
Brief Title:
Safety Study of an Intravenous Staphylococcus Aureus Immune Globulin Human Altastaph in Low-Birth-Weight-Neonates
Sponsor:
Nabi Biopharmaceuticals
Organization:
Nabi Biopharmaceuticals
Study Overview
Official Title:
A Double Blind Randomized Multicenter Stratified Study to Assess the Safety of an Intravenous Staphylococcus Aureus Immune Globulin Human Altastaph in Low-Birth-Weight-Neonates
Status:
COMPLETED
Status Verified Date:
2012-05
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 main objective will be to test the safety of two intravenous infusions of Altastaph a human immunoglobulin product The study will also test the ability of Altastaph to protect against S aureus infection
Detailed Description:
Survival of Very-Low-Birth-Weight VLBW infants 1500g at birth has improved dramatically but these patients remain subject to significant morbidity and mortality due to Staphylococcus aureus infection S aureus infection is a relatively common event in VLBW neonates occurring in approximately 34 of very low birth weight neonates and accounting for 15-20 of all infections in this patient population This controlled study will assess the safety pharmacokinetics and preliminary efficacy of Altastaph in LBW neonates The study will be stratified by birth weight and include up to 200 LBW neonates 3 to 7 days of age
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