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Completed Not applicable Interventional

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

ClinicalTrials.gov ID: NCT00113191

Public ClinicalTrials.gov record NCT00113191. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 8:50 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III, Randomized, Double-blind, Multi-center Clinical Trial Comparing the Safety and Efficacy of Veronate® Versus Placebo for the Prevention of Nosocomial Staphylococcal Sepsis in Premature Infants (Birth Weight 500 - 1250 g)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00113191
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Bristol-Myers Squibb
Industry
Enrollment
2,000 participants

Conditions and interventions

Eligibility (public fields only)

Age range
3 Days to 5 Days
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 2004 (Type not available)
Primary completion
Jun 2006 (Actual)
Completion
Jun 2006 (Actual)
Last update posted
Aug 2, 2012

2004 – 2006

United States locations

U.S. sites
85
U.S. states
30
U.S. cities
74
Facility City State ZIP Site status
Not listed Birmingham Alabama 35233 —
Not listed Mobile Alabama 36604 —
Not listed Anchorage Alaska 99508 —
Not listed Phoenix Arizona 85013 —
Not listed Phoenix Arizona 85016 —
Not listed Phoenix Arizona 85202 —
Not listed Hayward California 94545 —
Not listed Loma Linda California 92354 —
Not listed Long Beach California 90806 —
Not listed Oakland California 94611 —
Not listed Oakland California 94612 —
Not listed Orange California 92868 —
Not listed Sacramento California 95825 —
Not listed San Francisco California 94115 —
Not listed San Francisco California 94118 —
Not listed Santa Clara California 95051 —
Not listed Walnut Creek California 94596 —
Not listed Newark Delaware 19718 —
Not listed Washington D.C. District of Columbia 20010 —
Not listed Gainesville Florida 32610 —
Not listed Hollywood Florida 33012 —
Not listed Jacksonville Florida 32207 —
Not listed Jacksonville Florida 32209 —
Not listed Miami Florida 33155 —
Not listed Miami Florida 33176 —
Not listed Plantation Florida 33317 —
Not listed Tampa Florida 33606 —
Not listed Atlanta Georgia 30342 —
Not listed Augusta Georgia 30912 —
Not listed Honolulu Hawaii 96826 —
Not listed Evanston Illinois 60201 —
Not listed Park Ridge Illinois 60068 —
Not listed Indianapolis Indiana 46260 —
Not listed South Bend Indiana 46601 —
Not listed Wichita Kansas 67214 —
Not listed Baltimore Maryland 21201 —
Not listed Baltimore Maryland 21210 —
Not listed Detroit Michigan 48201 —
Not listed Detroit Michigan 48202 —
Not listed Detroit Michigan 48236 —
Not listed Flint Michigan 48503 —
Not listed Grand Rapids Michigan 49503 —
Not listed Lansing Michigan 48912 —
Not listed Royal Oak Michigan 48073 —
Not listed Duluth Minnesota 55805 —
Not listed Jackson Mississippi 39216 —
Not listed St Louis Missouri 63141 —
Not listed Camden New Jersey 08103 —
Not listed Newark New Jersey 07103 —
Not listed Voorhees Township New Jersey 08043 —
Not listed Albany New York 12208 —
Not listed Manhasset New York 11030 —
Not listed Mineola New York 11501 —
Not listed New Hyde Park New York 11040 —
Not listed Syracuse New York 13210 —
Not listed The Bronx New York 10804 —
Not listed Valhalla New York 10595 —
Not listed Charlotte North Carolina 28204 —
Not listed Charlotte North Carolina 28232 —
Not listed Greenville North Carolina 27835 —
Not listed Raleigh North Carolina 27610 —
Not listed Akron Ohio 44308 —
Not listed Cincinnati Ohio 45219 —
Not listed Columbus Ohio 43214 —
Not listed Dayton Ohio 45409 —
Not listed Toledo Ohio 43608 —
Not listed Youngstown Ohio 44501 —
Not listed Bryn Mawr Pennsylvania 19010 —
Not listed Philadelphia Pennsylvania 19102 —
Not listed Philadelphia Pennsylvania 19107 —
Not listed Pittsburgh Pennsylvania 15224 —
Not listed Wynnewood Pennsylvania 19096 —
Not listed Providence Rhode Island 02905 —
Not listed Greenville South Carolina 29605 —
Not listed Memphis Tennessee 38120 —
Not listed Dallas Texas 75246 —
Not listed Houston Texas 77030 —
Not listed San Antonio Texas 78229 —
Not listed Temple Texas 76508 —
Not listed Ogden Utah 84403 —
Not listed Provo Utah 84604 —
Not listed Salt Lake City Utah 84113 —
Not listed Charlottesville Virginia 22908 —
Not listed Spokane Washington 99204 —
Not listed Morgantown West Virginia 26506 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00113191, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 2, 2012 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00113191 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →