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

Sepsis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00113191
• Other study ID #: IgG-CL-006
• Status: Completed
• Phase: N/A
• First received: June 6, 2005
• Last updated: July 26, 2012
• Start date: May 2004
• Est. completion date: June 2006

Study information

• Verified date: July 2012
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Days

Eligibility

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

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

Related Conditions & MeSH terms

• Bacteremia
• Candidemia
• Cross Infection
• Infection
• Nosocomial Infections
• Sepsis
• Staphylococcal Infections
• Toxemia

Intervention

Drug:
• Veronate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the efficacy of Veronate® compared to placebo in preventing nosocomial S. aureus sepsis in premature infants
Primary	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	To compare the proportions of infants with nosocomial coagulase negative staphylococcus (CoNS) sepsis between premature infants treated with Veronate® versus placebo
Secondary	To compare the proportions of infants with all nosocomial staphylococcal sepsis between premature infants treated with Veronate® versus placebo
Secondary	To compare the proportions of infants with nosocomial candidemia between premature infants treated with Veronate® versus placebo
Secondary	To compare mortality between premature infants treated with Veronate® versus placebo