Safety and Behavior of S. Aureus Immune Globulin Intravenous(Human), [Altastaph] in Patients With S. Aureus Bacteremia and Continuing Fever

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00063089
First received: June 19, 2003
Last updated: May 10, 2012
Last verified: May 2012

June 19, 2003
May 10, 2012
September 2002
September 2004   (final data collection date for primary outcome measure)
Safety [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00063089 on ClinicalTrials.gov Archive Site
  • pharmacokinetics [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Efficacy [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
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Safety and Behavior of S. Aureus Immune Globulin Intravenous(Human), [Altastaph] in Patients With S. Aureus Bacteremia and Continuing Fever
Initial Safety and Pharmacokinetics Trial of Immune Globulin to Staphylococcus Aureus Capsule Polysaccharide (Altastaph) in Subjects With S. Aureus Bacteremia and Persistent Fever

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

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Staphylococcal Infections
Drug: S. aureus Immune Globulin Intravenous (Human) 5%
  • Experimental: altastaph
    S. aureus Immune Globulin Intravenous (Human) 5%
    Intervention: Drug: S. aureus Immune Globulin Intravenous (Human) 5%
  • Placebo Comparator: Placebo
    0.45% Normal Saline
    Intervention: Drug: S. aureus Immune Globulin Intravenous (Human) 5%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
September 2004
September 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female greater than or equal to 7 years of age
  • Weight less then or equal to 150 kilograms
  • Subjects willing to complete the full duration of the study, including the follow up visit to day 42
  • Life expectancy will enable the subject to complete the duration of the study
  • Female subjects of child-bearing potential, negative serum pregnancy test prior to the first infusion of study material. Female subjects of child-bearing potential must agree to use an effective method of birth control throughout the study. Abstinence is not considered an adequate birth control measure. Female subjects of non-child-bearing potential must have history of hysterectomy, bilateral surgical or radiation-induced oophorectomy, tubal ligation or evidence of post menopausal status
  • Subject, legal guardian(s) or medical power of attorney must have given written informed consent/ assent
  • S. aureus bacteremia and persistent fever. S. aureus bacteremia is defined as the first blood culture positive for S. aureus (index blood culture). 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
  • Absolute Neutrophil Count (ANC) greater then or equal to 500 x 10^9 cells/L
  • Subjects with malignancies may participate if:(1) The malignancy is a solid tumor (i.e. not lymphoma, leukemia, etc.)(2) The tumor has not metastasized to the bone marrow

Exclusion Criteria:

  • Known hypersensitivity or previous anaphylaxis to polysaccharide or polysaccharide-conjugate vaccines or to any component of Altastaph
  • Profound disability, assessed by the investigator, which would prevent participation in the study
  • Known IgA deficiency
  • Known HIV infection with CD4 count < 200 cells/L
  • Presence of any conditions which, in the opinion of the investigator, places the subject at undo risk or potentially jeopardizes the quality of the data to be generated
  • Pregnancy or breast feeding
  • Use of investigational drug or biologic in the four weeks prior to screening and during the study. The only exception is use of investigational antineoplastic product if, and only if: (1) The product is not expected to result in sever and prolonged immunosuppression (2) The product is, itself, not immunologically-based (e.g. anti-tumor/ monoclonal antibodies, cancer vaccines or interleukins
Both
7 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00063089
Nabi-1407
Not Provided
Nabi Biopharmaceuticals
Nabi Biopharmaceuticals
Not Provided
Not Provided
Nabi Biopharmaceuticals
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP