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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:
ClinicalTrials.gov Identifier:
NCT00063089
First Posted: June 20, 2003
Last Update Posted: May 14, 2012
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.
Information provided by (Responsible Party):
Nabi Biopharmaceuticals
June 19, 2003
June 20, 2003
May 14, 2012
September 2002
September 2004   (Final data collection date for primary outcome measure)
Safety [ Time Frame: 6 weeks ]
Not Provided
Complete list of historical versions of study NCT00063089 on ClinicalTrials.gov Archive Site
  • pharmacokinetics [ Time Frame: 6 weeks ]
  • Efficacy [ Time Frame: 6 Weeks ]
Not Provided
Not Provided
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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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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%
Rupp ME, Holley HP Jr, Lutz J, Dicpinigaitis PV, Woods CW, Levine DP, Veney N, Fowler VG Jr. Phase II, randomized, multicenter, double-blind, placebo-controlled trial of a polyclonal anti-Staphylococcus aureus capsular polysaccharide immune globulin in treatment of Staphylococcus aureus bacteremia. Antimicrob Agents Chemother. 2007 Dec;51(12):4249-54. Epub 2007 Sep 24.

*   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
Sexes Eligible for Study: All
7 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00063089
Nabi-1407
Not Provided
Not Provided
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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