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

Not Applicable

Completed

• Conditions: Sepsis; Nosocomial Infections; Staphylococcal Infections; Candidemia

• Registration Number: NCT00113191
• Lead Sponsor: Bristol-Myers Squibb

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2005-06-06
• Study First Submitted QC: 2005-06-06
• Study First Posted: 2005-06-07
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2012-07
• Disposition First Submitted: 2012-07-26
• Disposition First Submitted QC: 2012-07-26
• Last Update Submitted: 2012-07-26
• Disposition First Posted: 2012-08-02
• Last Update Posted: 2012-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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