deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 2-arm NCT00063089

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

Sponsor: Nabi Biopharmaceuticals

Conditions Staphylococcal Infections
Interventions S. aureus Immune Globulin Intravenous (Human) 5%
Updated 7 times since 2017 Last updated: May 10, 2012 Started: Sep 30, 2002 Primary completion: Sep 30, 2004 Completion: Sep 30, 2004
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00063089, this PHASE1/PHASE2 trial focuses on Staphylococcal Infections and remains completed. Sponsored by Nabi Biopharmaceuticals, it has been updated 7 times since 2002, reflecting limited change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Study Description(click to expand)

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.

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.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

7 versions recorded

  1. Jan 2026 — Present [monthly]

    Completed PHASE1/PHASE2

  2. Sep 2024 — Present [monthly]

    Completed PHASE1/PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1_PHASE2

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE1_PHASE2

▶ Show 2 earlier versions

  1. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE1_PHASE2

  2. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE1_PHASE2

    First recorded

Sep 2002

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Nabi Biopharmaceuticals
Data source: Nabi Biopharmaceuticals

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.