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

This study is currently recruiting patients.

Sponsored by: Inhibitex
Information provided by: Inhibitex

Purpose

The purpose of this study is to show whether Veronate 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 Treatment or Intervention Phase
Nosocomial Infections
Sepsis
Staphylococcal Infections
Candidemia
 Drug: Veronate - a donor-selected staphylococcal human immune globulin intravenous (IGIV)
Phase III

MedlinePlus related topics:  Sepsis;   Staphylococcal Infections

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy 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)

Further Study Details: 
Primary Outcomes: 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 Outcomes: 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
Expected Total Enrollment:  2000

Study start: May 2004

Eligibility

Ages Eligible for Study:  up to  5 Days,  Genders Eligible for Study:  Both

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00113191

Amy Morris, MBA      678.746.1106    amorris@inhibitex.com

Georgia
      100 sites throughout the US and Canada, Alpharetta,  Georgia,  30004,  United States; Recruiting

Study chairs or principal investigators

Seth V. Hetherington, MD,  Study Director,  Inhibitex   

More Information

Study ID Numbers:  IgG-CL-006
Record last reviewed:  June 2005
Last Updated:  June 6, 2005
Record first received:  June 6, 2005
ClinicalTrials.gov Identifier:  NCT00113191
Health Authority: United States: Food and Drug Administration; Canada: Health Canada (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-06-07

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