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

Primary Purpose

Staphylococcal Infections

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
S. aureus Immune Globulin Intravenous (Human) 5%
Sponsored by
Nabi Biopharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Staphylococcal Infections focused on measuring Staphylococcal infection, Gram positive bacteria, Staphylococcus, Staphylococcus aureus

Eligibility Criteria

7 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    altastaph

    Placebo

    Arm Description

    S. aureus Immune Globulin Intravenous (Human) 5%

    0.45% Normal Saline

    Outcomes

    Primary Outcome Measures

    Safety

    Secondary Outcome Measures

    pharmacokinetics
    Efficacy

    Full Information

    First Posted
    June 19, 2003
    Last Updated
    May 10, 2012
    Sponsor
    Nabi Biopharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00063089
    Brief Title
    Safety and Behavior of S. Aureus Immune Globulin Intravenous(Human), [Altastaph] in Patients With S. Aureus Bacteremia and Continuing Fever
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2002 (undefined)
    Primary Completion Date
    September 2004 (Actual)
    Study Completion Date
    September 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nabi Biopharmaceuticals

    4. Oversight

    5. Study Description

    Brief Summary
    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
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Staphylococcal Infections
    Keywords
    Staphylococcal infection, Gram positive bacteria, Staphylococcus, Staphylococcus aureus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    altastaph
    Arm Type
    Experimental
    Arm Description
    S. aureus Immune Globulin Intravenous (Human) 5%
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    0.45% Normal Saline
    Intervention Type
    Drug
    Intervention Name(s)
    S. aureus Immune Globulin Intravenous (Human) 5%
    Primary Outcome Measure Information:
    Title
    Safety
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    pharmacokinetics
    Time Frame
    6 weeks
    Title
    Efficacy
    Time Frame
    6 Weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17893153
    Citation
    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. doi: 10.1128/AAC.00570-07. Epub 2007 Sep 24.
    Results Reference
    derived

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

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