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

July 26, 2012 updated by: Bristol-Myers Squibb

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3 W7
      • Vancouver, British Columbia, Canada, V6H 3V4
      • Victoria, British Columbia, Canada, V8Z 6R5
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
      • Windsor, Ontario, Canada, N8W 1L9
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
      • Mobile, Alabama, United States, 36604
    • Alaska
      • Anchorage, Alaska, United States, 99508
    • Arizona
      • Phoenix, Arizona, United States, 85013
      • Phoenix, Arizona, United States, 85016
      • Phoenix, Arizona, United States, 85202
    • California
      • Hayward, California, United States, 94545
      • Loma Linda, California, United States, 92354
      • Long Beach, California, United States, 90806
      • Oakland, California, United States, 94611
      • Oakland, California, United States, 94612
      • Orange, California, United States, 92868
      • Sacramento, California, United States, 95825
      • San Francisco, California, United States, 94115
      • San Francisco, California, United States, 94118
      • Santa Clara, California, United States, 95051
      • Walnut Creek, California, United States, 94596
    • Delaware
      • Newark, Delaware, United States, 19718
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Florida
      • Gainesville, Florida, United States, 32610
      • Hollywood, Florida, United States, 33012
      • Jacksonville, Florida, United States, 32207
      • Jacksonville, Florida, United States, 32209
      • Miami, Florida, United States, 33155
      • Miami, Florida, United States, 33176
      • Plantation, Florida, United States, 33317
      • Tampa, Florida, United States, 33606
    • Georgia
      • Atlanta, Georgia, United States, 30342
      • Augusta, Georgia, United States, 30912
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
    • Illinois
      • Evanston, Illinois, United States, 60201
      • Park Ridge, Illinois, United States, 60068
    • Indiana
      • Indianapolis, Indiana, United States, 46260
      • South Bend, Indiana, United States, 46601
    • Kansas
      • Wichita, Kansas, United States, 67214
    • Maryland
      • Baltimore, Maryland, United States, 21201
      • Baltimore, Maryland, United States, 21210
    • Michigan
      • Detroit, Michigan, United States, 48201
      • Detroit, Michigan, United States, 48236
      • Detroit, Michigan, United States, 48202
      • Flint, Michigan, United States, 48503
      • Grand Rapids, Michigan, United States, 49503
      • Lansing, Michigan, United States, 48912
      • Royal Oak, Michigan, United States, 48073
    • Minnesota
      • Duluth, Minnesota, United States, 55805
    • Mississippi
      • Jackson, Mississippi, United States, 39216
    • Missouri
      • St. Louis, Missouri, United States, 63141
    • New Jersey
      • Camden, New Jersey, United States, 08103
      • Newark, New Jersey, United States, 07103
      • Voorhees, New Jersey, United States, 08043
    • New York
      • Albany, New York, United States, 12208
      • Bronx, New York, United States, 10804
      • Manhasset, New York, United States, 11030
      • Mineola, New York, United States, 11501
      • New Hyde Park, New York, United States, 11040
      • Syracuse, New York, United States, 13210
      • Valhalla, New York, United States, 10595
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
      • Charlotte, North Carolina, United States, 28232
      • Greenville, North Carolina, United States, 27835
      • Raleigh, North Carolina, United States, 27610
    • Ohio
      • Akron, Ohio, United States, 44308
      • Cincinnati, Ohio, United States, 45219
      • Columbus, Ohio, United States, 43214
      • Dayton, Ohio, United States, 45409
      • Toledo, Ohio, United States, 43608
      • Youngstown, Ohio, United States, 44501
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
      • Philadelphia, Pennsylvania, United States, 19107
      • Philadelphia, Pennsylvania, United States, 19102
      • Pittsburgh, Pennsylvania, United States, 15224
      • Wynnewood, Pennsylvania, United States, 19096
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
    • South Carolina
      • Greenville, South Carolina, United States, 29605
    • Tennessee
      • Memphis, Tennessee, United States, 38120
    • Texas
      • Dallas, Texas, United States, 75246
      • Houston, Texas, United States, 77030
      • San Antonio, Texas, United States, 78229
      • Temple, Texas, United States, 76508
    • Utah
      • Ogden, Utah, United States, 84403
      • Provo, Utah, United States, 84604
      • Salt Lake City, Utah, United States, 84113
    • Virginia
      • Charlottesville, Virginia, United States, 22908
    • Washington
      • Spokane, Washington, United States, 99204
    • West Virginia
      • Morgantown, West Virginia, United States, 26506

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 5 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent obtained from parent or legal guardian
  • Birth weight 500 to 1250 g, inclusive
  • Age 3 - 5 days (49 to 120 hours), inclusive
  • Expected to require IV access for medical care through day of life 14

Exclusion Criteria:

  • Already received or likely to receive prior to first infusion of Study Drug:

    • IGIV or *immune globulin for prevention of Hepatitis B
  • Receiving an agent for prevention of staphylococcal catheter related or nosocomial infections (e.g., vancomycin)

  • Active sepsis, as defined by one of the following:

    • culture proven early onset sepsis and not clinically stable; or
    • clinical signs of sepsis and pending blood cultures; if the blood cultures are negative after 48 hours and the infant is clinically stable, the infant may be randomized
  • Severe congenital anomaly, where the prospects for survival, the medical complications and treatment, would compromise the study related outcome evaluation(s) in the Investigator's opinion
  • Diagnosis of congenital immunodeficiency
  • Evidence of significant fluid overload or significant volume depletion
  • Evidence of abnormal renal function as measured by serum creatinine > 1.6 mg/dL

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: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To assess the efficacy of Veronate® compared to placebo in preventing nosocomial S. aureus sepsis in premature infants
To assess the safety profile of Veronate® compared to placebo in premature infants as measured by frequencies of adverse events, serious adverse events and morbidities associated with prematurity

Secondary Outcome Measures

Outcome Measure
To compare the proportions of infants with nosocomial coagulase negative staphylococcus (CoNS) sepsis between premature infants treated with Veronate® versus placebo
To compare the proportions of infants with all nosocomial staphylococcal sepsis between premature infants treated with Veronate® versus placebo
To compare the proportions of infants with nosocomial candidemia between premature infants treated with Veronate® versus placebo
To compare mortality between premature infants treated with Veronate® versus placebo

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Seth V. Hetherington, MD, Inhibitex

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2004

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

June 6, 2005

First Submitted That Met QC Criteria

June 6, 2005

First Posted (Estimate)

June 7, 2005

Study Record Updates

Last Update Posted (Estimate)

August 2, 2012

Last Update Submitted That Met QC Criteria

July 26, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IgG-CL-006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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