Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00063089
Status:
COMPLETED
Last Update Posted:
2012-05-14
First Post:
2003-06-19
Brief Title:
Safety and Behavior of S Aureus Immune Globulin IntravenousHuman Altastaph in Patients With S Aureus Bacteremia and Continuing Fever
Sponsor:
Nabi Biopharmaceuticals
Organization:
Nabi Biopharmaceuticals
Study Overview
Official Title:
Initial Safety and Pharmacokinetics Trial of Immune Globulin to Staphylococcus Aureus Capsule Polysaccharide Altastaph in Subjects With S Aureus Bacteremia and Persistent Fever
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:
Altastaph has been developed to help the removal of S aureus from the bloodstream The main objective of this study will be to test the safety and behavior of Altastaph in patients with Saureus bacteremia and continuing fever
Detailed Description:
Staphylococcus aureus has been recognized as an important community - acquired and nosocomial pathogen Because it is a common cause of osteomyelitis endocarditis and meningitis S aureus infections lead to considerable morbidity and mortality The main objective of this study will be to test the safety and pharmacokinetics of Altastaph in patients with S aureus bacteremia and persistent fever This study will also assess the efficacy of Altastaph versus control
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