Safety Study of an Intravenous Staphylococcus Aureus Immune Globulin (Human), [Altastaph] in Low-Birth-Weight-Neonates
This study has been completed.
First Posted: August 11, 2003
Last Update Posted: May 14, 2012
Information provided by (Responsible Party):
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.
|Staphylococcal Infections||Drug: Staphylococcus aureus Immune Globulin (Human) 5%||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Nabi Biopharmaceuticals:
|Study Start Date:||July 2003|
|Study Completion Date:||August 2004|
|Primary Completion Date:||August 2004 (Final data collection date for primary outcome measure)|
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 3.4% 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.
Contacts and Locations
No Contacts or Locations Provided