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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00113191
First received: June 6, 2005
Last updated: July 26, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Nosocomial Infections
Sepsis
Staphylococcal Infections
Candidemia
Drug: Veronate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 2000
Study Start Date: May 2004
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 5 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113191

  Show 93 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Seth V. Hetherington, MD Inhibitex
  More Information

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00113191     History of Changes
Other Study ID Numbers: IgG-CL-006
Study First Received: June 6, 2005
Last Updated: July 26, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Bristol-Myers Squibb:
late onset sepsis
premature infants
staphylococcus
candida
prevention

Additional relevant MeSH terms:
Infection
Communicable Diseases
Sepsis
Toxemia
Candidemia
Cross Infection
Staphylococcal Infections
Bacteremia
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Fungemia
Candidiasis, Invasive
Candidiasis
Mycoses
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 22, 2014