Safety and Efficacy of Veronate® Versus Placebo in Preventing Nosocomial Staphylococcal Sepsis in Premature Infants - Full Text View

Sponsored by:	Inhibitex
Information provided by:	Inhibitex
ClinicalTrials.gov Identifier:	NCT00113191

Purpose

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.

Condition	Intervention
Nosocomial Infections Sepsis Staphylococcal Infections Candidemia	Drug: Veronate

MedlinePlus related topics: Premature Babies Sepsis Staphylococcal Infections

U.S. FDA Resources

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 as provided by Inhibitex:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	2000
Study Start Date:	May 2004
Study Completion Date:	June 2006

Eligibility

Ages Eligible for Study:	up to 5 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113191

Show 93 Study Locations

Sponsors and Collaborators

Inhibitex

Investigators

Study Director:

Seth V. Hetherington, MD

Inhibitex

More Information

Inhibitex Home Page This link exits the ClinicalTrials.gov site

Publications indexed to this study:

DeJonge M, Burchfield D, Bloom B, Duenas M, Walker W, Polak M, Jung E, Millard D, Schelonka R, Eyal F, Morris A, Kapik B, Roberson D, Kesler K, Patti J, Hetherington S. Clinical trial of safety and efficacy of IHN-A21 for the prevention of nosocomial staphylococcal bloodstream infection in premature infants. J Pediatr. 2007 Sep;151(3):260-5, 265.e1. Epub 2007 Jul 24.

Study ID Numbers:	IgG-CL-006
Study First Received:	June 6, 2005
Last Updated:	April 4, 2007
ClinicalTrials.gov Identifier:	NCT00113191
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Inhibitex:

late onset sepsis
premature infants
staphylococcus
candida
prevention

Study placed in the following topic categories:

Bacterial Infections
Systemic Inflammatory Response Syndrome
Body Weight
Birth Weight
Staphylococcal Infections

Gram-Positive Bacterial Infections
Sepsis
Torulopsis
Cross Infection
Inflammation

Additional relevant MeSH terms:

Communicable Diseases
Pathologic Processes
Infection

ClinicalTrials.gov processed this record on January 16, 2009