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Sponsored by: |
Nabi Biopharmaceuticals |
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Information provided by: | Nabi Biopharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00066989 |
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.
Condition | Intervention | Phase |
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Staphylococcal Infections |
Drug: Staphylococcus aureus Immune Globulin (Human) 5% |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
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 |
Estimated Enrollment: | 200 |
Study Start Date: | July 2003 |
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.
Ages Eligible for Study: | up to 7 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
The subject must conform to all of the following (Inclusion Criteria):
The subject must not have any of the following (Exclusion Criteria):
Study ID Numbers: | Nabi-1408 |
Study First Received: | August 8, 2003 |
Last Updated: | July 11, 2005 |
ClinicalTrials.gov Identifier: | NCT00066989 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Staphylococcal infection Gram positive bacteria Staphylococcus Staphylococcus aureus |
Bacterial Infections Body Weight Birth Weight Signs and Symptoms Staphylococcal Infections |
Antibodies Gram-Positive Bacterial Infections Immunologic Factors Immunoglobulins |
Bacterial Infections Body Weight Birth Weight Signs and Symptoms Staphylococcal Infections Antibodies |
Gram-Positive Bacterial Infections Immunologic Factors Physiological Effects of Drugs Infection Pharmacologic Actions Immunoglobulins |