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

Staphylococcal Infections Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Birth Weight
• Staphylococcal Infections

• NCT number: NCT00066989
• Study type: Interventional
• Source: Nabi Biopharmaceuticals
• Status: Completed
• Phase: Phase 2
• Start date: July 2003
• Completion date: August 2004