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Completed

NCT Number: NCT00113191

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

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.

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Key information

Conditions

Nosocomial Infections Bacterial Infections Bacterial Infections and Mycoses Candidemia Candidiasis Candidiasis, Invasive Cross Infection Disease Attributes Female Urogenital Diseases and Pregnancy Complications Fungemia Gram-Positive Bacterial Infections Iatrogenic Disease Infections Inflammation Invasive Fungal Infections Mycoses Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Sepsis Staphylococcal Infections Systemic Inflammatory Response Syndrome Torulopsis Urogenital Diseases

Age range

3 day–5 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Westminster, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Veronate

Drug

Primary outcomes

  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

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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)

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Jun 7, 2005
Registry last updated
Aug 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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