NCT00066989

Safety Study of an Intravenous Staphylococcus Aureus Immune Globulin (Human), [Altastaph] in Low-Birth-Weight-Neonates

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (planned)
• Sponsor: Nabi Biopharmaceuticals · Industry
• Sex: All
• Age: 3 Days – 7 Days
• Healthy volunteers: Not accepted

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 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.

Conditions

• Staphylococcal Infections

Interventions

Type	Name	Description
DRUG	Staphylococcus aureus Immune Globulin (Human) 5%

Timeline

• Start date: 2003-07-01
• Primary completion: 2004-08-01
• Completion: 2004-08-01
• First posted: 2003-08-11
• Last updated: 2012-05-14