Safety Study of an Intravenous Staphylococcus Aureus Immune Globulin (Human), [Altastaph] in Low-Birth-Weight-Neonates

May 10, 2012 updated by: Nabi Biopharmaceuticals

A Double Blind, Randomized, Multicenter Stratified Study to Assess the Safety of an Intravenous Staphylococcus Aureus Immune Globulin (Human) [Altastaph] in Low-Birth-Weight-Neonates

The main objective will be to test the safety of two intravenous infusions of Altastaph, a human immunoglobulin product. The study will also test the ability of Altastaph to protect against S. aureus infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Survival of Very-Low-Birth-Weight (VLBW) infants (<1500g at birth) has improved dramatically, but these patients remain subject to significant morbidity and mortality due to Staphylococcus aureus infection. S. aureus infection is a relatively common event in VLBW neonates, occurring in approximately 3.4% of very low birth weight neonates and accounting for 15-20% of all infections in this patient population. This controlled study will assess the safety, pharmacokinetics, and preliminary efficacy of Altastaph in LBW neonates. The study will be stratified by birth weight and include up to 200 LBW neonates, 3 to 7 days of age.

Study Type

Interventional

Enrollment

200

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 days to 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

The subject must conform to all of the following (Inclusion Criteria):

  • Neonate with a birth weight between 501 and 1500 grams inclusive;
  • Between 3 and 7 days of age, inclusive, at the time of first infusion (Day 0);
  • Expected to survive at least 48 hours after infusion;
  • Free of overt systemic infection, as determined by history, physical examination, radiologic studies, or laboratory studies including microbiology data; clinical safety tests required can be completed up to three (3) days prior to the infusion of the study product;
  • Direct bilirubin less than or equal to 2.0 mg/dL;
  • Serum creatinine level of less than or equal to 2.0 mg/dL; and
  • Hemodynamically stabile; if the subject is receiving cardiac support including anti-arrhythmics, pressors, or cardiac pacing, the subject must be stable on that cardiac support and be expected not to require this support indefinitely.

The subject must not have any of the following (Exclusion Criteria):

  • Known HIV infection, as documented by maternal history or positive PCR in the infant;
  • Severe congenital anomaly or genetic disorder known to impact immune competence;
  • Prior administration of any immune globulin;
  • Any history, in the infant subject or its mother, of hypersensitivity or severe vasomotor reaction to any human blood product;
  • Cyanotic congenital heart disease; and
  • Central nervous system shunt

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nabi Biopharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

August 1, 2004

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

August 8, 2003

First Submitted That Met QC Criteria

August 8, 2003

First Posted (Estimate)

August 11, 2003

Study Record Updates

Last Update Posted (Estimate)

May 14, 2012

Last Update Submitted That Met QC Criteria

May 10, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nabi-1408

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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