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
  Purpose

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


Condition Intervention Phase
Staphylococcal Infections
Drug: S. aureus Immune Globulin Intravenous (Human) 5%
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Nabi Biopharmaceuticals:

Primary Outcome Measures:
  • Safety [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • pharmacokinetics [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Efficacy [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: September 2002
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: altastaph
S. aureus Immune Globulin Intravenous (Human) 5%
Drug: S. aureus Immune Globulin Intravenous (Human) 5%
Placebo Comparator: Placebo
0.45% Normal Saline
Drug: S. aureus Immune Globulin Intravenous (Human) 5%

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.

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided

Responsible Party: Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT00063089     History of Changes
Other Study ID Numbers: Nabi-1407
Study First Received: June 19, 2003
Last Updated: May 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Nabi Biopharmaceuticals:
Staphylococcal infection
Gram positive bacteria
Staphylococcus
Staphylococcus aureus

Additional relevant MeSH terms:
Bacteremia
Staphylococcal Infections
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Gram-Positive Bacterial Infections
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014