MedTrace Logo

Safety and Efficacy of Veronate® Versus Placebo in Preventing Nosocomial Staphylococcal Sepsis in Premature Infants

NCT00113191 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2012-08-02

No results posted yet for this study

Summary

The purpose of this study is to show whether Veronate, a donor-selected staphylococcal human immune globulin intravenous (IGIV), can prevent an infection in the blood caused by staphylococcal bacteria in premature babies weighing between 500 and 1250 grams at birth.

Babies are enrolled between Day of Life 3 and 5. Babies are randomized to either Veronate or placebo (50-50 chance of either). Babies can receive up to 4 doses of the study drug on Study Days 1, 3, 8 and 15 and are followed until Study Day 70 or discharge from the hospital.

Conditions

  • Nosocomial Infections
  • Sepsis
  • Staphylococcal Infections
  • Candidemia

Interventions

DRUG

Veronate

Sponsors & Collaborators

Principal Investigators

  • Seth V. Hetherington, MD · Inhibitex

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Days
Max Age
5 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2006-06-30
Completion
2006-06-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00113191 on ClinicalTrials.gov