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Nosocomial InfectionsNCT00113191

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

A study testing Veronate in people with Nosocomial Infections and Sepsis, run by Bristol-Myers Squibb at 93 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 5 days
What is being tested?
Veronate
How many people
2,000 participants
Where
93 sitesin 2 countries
Study dates
May 2004to Jun 2006
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 5 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

93 sites in 2 countries.

93 sites in 2 countries

United States85 sites

  • Study site

    Akron, Ohio, 44308

  • Study site

    Albany, New York, 12208

  • Study site

    Anchorage, Alaska, 99508

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Augusta, Georgia, 30912

  • Study site

    Baltimore, Maryland, 21201

  • Study site

    Baltimore, Maryland, 21210

  • Study site

    Birmingham, Alabama, 35233

  • Study site

    Bryn Mawr, Pennsylvania, 19010

  • Study site

    Camden, New Jersey, 08103

  • Study site

    Charlotte, North Carolina, 28204

  • Study site

    Charlotte, North Carolina, 28232

  • Study site

    Charlottesville, Virginia, 22908

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Columbus, Ohio, 43214

  • Study site

    Dallas, Texas, 75246

  • Study site

    Dayton, Ohio, 45409

  • Study site

    Detroit, Michigan, 48201

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Detroit, Michigan, 48236

  • Study site

    Duluth, Minnesota, 55805

  • Study site

    Evanston, Illinois, 60201

  • Study site

    Flint, Michigan, 48503

  • Study site

    Gainesville, Florida, 32610

  • Study site

    Grand Rapids, Michigan, 49503

  • Study site

    Greenville, North Carolina, 27835

  • Study site

    Greenville, South Carolina, 29605

  • Study site

    Hayward, California, 94545

  • Study site

    Hollywood, Florida, 33012

  • Study site

    Honolulu, Hawaii, 96826

  • Study site

    Houston, Texas, 77030

  • Study site

    Indianapolis, Indiana, 46260

  • Study site

    Jackson, Mississippi, 39216

  • Study site

    Jacksonville, Florida, 32207

  • Study site

    Jacksonville, Florida, 32209

  • Study site

    Lansing, Michigan, 48912

  • Study site

    Loma Linda, California, 92354

  • Study site

    Long Beach, California, 90806

  • Study site

    Manhasset, New York, 11030

  • Study site

    Memphis, Tennessee, 38120

  • Study site

    Miami, Florida, 33155

  • Study site

    Miami, Florida, 33176

  • Study site

    Mineola, New York, 11501

  • Study site

    Mobile, Alabama, 36604

  • Study site

    Morgantown, West Virginia, 26506

  • Study site

    New Hyde Park, New York, 11040

  • Study site

    Newark, Delaware, 19718

  • Study site

    Newark, New Jersey, 07103

  • Study site

    Oakland, California, 94611

  • Study site

    Oakland, California, 94612

  • Study site

    Ogden, Utah, 84403

  • Study site

    Orange, California, 92868

  • Study site

    Park Ridge, Illinois, 60068

  • Study site

    Philadelphia, Pennsylvania, 19102

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Phoenix, Arizona, 85013

  • Study site

    Phoenix, Arizona, 85016

  • Study site

    Phoenix, Arizona, 85202

  • Study site

    Pittsburgh, Pennsylvania, 15224

  • Study site

    Plantation, Florida, 33317

  • Study site

    Providence, Rhode Island, 02905

  • Study site

    Provo, Utah, 84604

  • Study site

    Raleigh, North Carolina, 27610

  • Study site

    Royal Oak, Michigan, 48073

  • Study site

    Sacramento, California, 95825

  • Study site

    Salt Lake City, Utah, 84113

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Francisco, California, 94115

  • Study site

    San Francisco, California, 94118

  • Study site

    Santa Clara, California, 95051

  • Study site

    South Bend, Indiana, 46601

  • Study site

    Spokane, Washington, 99204

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Syracuse, New York, 13210

  • Study site

    Tampa, Florida, 33606

  • Study site

    Temple, Texas, 76508

  • Study site

    The Bronx, New York, 10804

  • Study site

    Toledo, Ohio, 43608

  • Study site

    Valhalla, New York, 10595

  • Study site

    Voorhees Township, New Jersey, 08043

  • Study site

    Walnut Creek, California, 94596

  • Study site

    Washington D.C., District of Columbia, 20010

  • Study site

    Wichita, Kansas, 67214

  • Study site

    Wynnewood, Pennsylvania, 19096

  • Study site

    Youngstown, Ohio, 44501

Other trials in United States

Canada8 sites

  • Study site

    Halifax, Nova Scotia, B3K 6R8

  • Study site

    Kingston, Ontario, K7L 2V7

  • Study site

    Montreal, Quebec, H3T 1E2

  • Study site

    New Westminster, British Columbia, V3L 3 W7

  • Study site

    Saskatoon, Saskatchewan, S7N 0W8

  • Study site

    Vancouver, British Columbia, V6H 3V4

  • Study site

    Victoria, British Columbia, V8Z 6R5

  • Study site

    Windsor, Ontario, N8W 1L9

Other trials in Canada

About this study

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)

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.

Being tested
Veronate
Keywords
late onset sepsis, premature infants, staphylococcus, candida, prevention
Medical subject headings
Cross Infection, Sepsis, Staphylococcal Infections, Candidemia, Premature Birth, Torulopsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VeronateDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the efficacy of Veronate® compared to placebo in preventing nosocomial S. aureus sepsis in premature infants

  2. 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 outcomes (4)

  1. To compare the proportions of infants with nosocomial coagulase negative staphylococcus (CoNS) sepsis between premature infants treated with Veronate® versus placebo

  2. To compare the proportions of infants with all nosocomial staphylococcal sepsis between premature infants treated with Veronate® versus placebo

  3. To compare the proportions of infants with nosocomial candidemia between premature infants treated with Veronate® versus placebo

  4. To compare mortality between premature infants treated with Veronate® versus placebo

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2005 (estimated)
  2. Study startMay 2004
  3. Primary completionJun 2006
  4. Study completionJun 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Enrolment
2,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00113191
Sponsor's protocol ID
IgG-CL-006
Status last verified
Jul 2012
First submitted
6 Jun 2005
Last updated
2 Aug 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • DeJonge M, Burchfield D, Bloom B, Duenas M, Walker W, Polak M, Jung E, Millard D, Schelonka R, Eyal F, Morris A, Kapik B, Roberson D, Kesler K, Patti J, Hetherington S. Clinical trial of safety and efficacy of INH-A21 for the prevention of nosocomial staphylococcal bloodstream infection in premature infants. J Pediatr. 2007 Sep;151(3):260-5, 265.e1. doi: 10.1016/j.jpeds.2007.04.060. Epub 2007 Jul 24.

    PubMed 17719934

Questions about this trial

What is this clinical trial studying?

A study testing Veronate in people with Nosocomial Infections and Sepsis, run by Bristol-Myers Squibb at 93 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the efficacy of Veronate® compared to placebo in preventing nosocomial S. aureus sepsis in premature infants. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00113191, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2012.

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