NCT00066989

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2003

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 8, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2003

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
Last Updated

May 14, 2012

Status Verified

May 1, 2012

Enrollment Period

1.1 years

First QC Date

August 8, 2003

Last Update Submit

May 10, 2012

Conditions

Staphylococcal Infections

Keywords

Staphylococcal infectionGram positive bacteriaStaphylococcusStaphylococcus aureus

Interventions

Staphylococcus aureus Immune Globulin (Human) 5%DRUG

Eligibility Criteria

Age3 Days - 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2003

First Posted

August 11, 2003

Study Start

July 1, 2003

Primary Completion

August 1, 2004

Study Completion

August 1, 2004

Last Updated

May 14, 2012

Record last verified: 2012-05