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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00066989
Recruitment Status : Completed
First Posted : August 11, 2003
Last Update Posted : May 14, 2012
Information provided by (Responsible Party):
Nabi Biopharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Staphylococcal Infections Drug: Staphylococcus aureus Immune Globulin (Human) 5% Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
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
Study Start Date : July 2003
Actual Primary Completion Date : August 2004
Actual Study Completion Date : August 2004

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

The subject must conform to all of the following (Inclusion Criteria):

  • Neonate with a birth weight between 501 and 1500 grams inclusive;
  • Between 3 and 7 days of age, inclusive, at the time of first infusion (Day 0);
  • Expected to survive at least 48 hours after infusion;
  • Free of overt systemic infection, as determined by history, physical examination, radiologic studies, or laboratory studies including microbiology data; clinical safety tests required can be completed up to three (3) days prior to the infusion of the study product;
  • Direct bilirubin less than or equal to 2.0 mg/dL;
  • Serum creatinine level of less than or equal to 2.0 mg/dL; and
  • Hemodynamically stabile; if the subject is receiving cardiac support including anti-arrhythmics, pressors, or cardiac pacing, the subject must be stable on that cardiac support and be expected not to require this support indefinitely.

The subject must not have any of the following (Exclusion Criteria):

  • Known HIV infection, as documented by maternal history or positive PCR in the infant;
  • Severe congenital anomaly or genetic disorder known to impact immune competence;
  • Prior administration of any immune globulin;
  • Any history, in the infant subject or its mother, of hypersensitivity or severe vasomotor reaction to any human blood product;
  • Cyanotic congenital heart disease; and
  • Central nervous system shunt
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Responsible Party: Nabi Biopharmaceuticals Identifier: NCT00066989    
Other Study ID Numbers: Nabi-1408
First Posted: August 11, 2003    Key Record Dates
Last Update Posted: May 14, 2012
Last Verified: May 2012
Keywords provided by Nabi Biopharmaceuticals:
Staphylococcal infection
Gram positive bacteria
Staphylococcus aureus
Additional relevant MeSH terms:
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Staphylococcal Infections
Birth Weight
Body Weight
Gram-Positive Bacterial Infections
Bacterial Infections
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs