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| Sponsored by: |
Nabi Biopharmaceuticals |
|---|---|
| Information provided by: | Nabi Biopharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00063089 |
Purpose
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 S.aureus bacteremia and continuing fever
| Condition | Intervention | Phase |
|---|---|---|
|
Staphylococcal Infections |
Drug: S. aureus Immune Globulin Intravenous (Human) 5% |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
| 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 |
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2002 |
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.
Eligibility| Ages Eligible for Study: | 7 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Persistent fever (qualifying fever) is defined as a temperature (greater then or equal to 100.4F or greater then or equal to 38C) occuring at least 24 hours after the index temperature was recorded and after the index blood culture was drawn
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | Nabi-1407 |
| Study First Received: | June 19, 2003 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00063089 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Staphylococcal infection Gram positive bacteria Staphylococcus Staphylococcus aureus |
|
Bacterial Infections Systemic Inflammatory Response Syndrome Immunologic Factors Bacteremia Inflammation Fever Staphylococcal Infections |
Sepsis Gram-Positive Bacterial Infections Antibodies Immunoglobulins, Intravenous Rho(D) Immune Globulin Immunoglobulins |
|
Bacterial Infections Systemic Inflammatory Response Syndrome Immunologic Factors Physiological Effects of Drugs Bacteremia Infection Pharmacologic Actions Inflammation |
Staphylococcal Infections Sepsis Gram-Positive Bacterial Infections Antibodies Pathologic Processes Immunoglobulins, Intravenous Rho(D) Immune Globulin Immunoglobulins |