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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Sepsis, Nosocomial Infections, Staphylococcal Infections, Candidemia

Intervention / Treatment
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* Drug: Veronate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Days
Maximum Age: 5 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Veronate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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late onset sepsis, premature infants, staphylococcus, candida, prevention