Safety and Efficacy of Veronate® Versus Placebo in Preventing Nosocomial Staphylococcal Sepsis in Premature Infants
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)
1 other identifier
interventional
2,000
2 countries
93
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2004
Typical duration for not_applicable
93 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 6, 2005
CompletedFirst Posted
Study publicly available on registry
June 7, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedAugust 2, 2012
July 1, 2012
2.1 years
June 6, 2005
July 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 (4)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (93)
Unknown Facility
Birmingham, Alabama, 35233, United States
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Mobile, Alabama, 36604, United States
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Anchorage, Alaska, 99508, United States
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Phoenix, Arizona, 85013, United States
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Phoenix, Arizona, 85016, United States
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Phoenix, Arizona, 85202, United States
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Hayward, California, 94545, United States
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Loma Linda, California, 92354, United States
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Long Beach, California, 90806, United States
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Oakland, California, 94611, United States
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Oakland, California, 94612, United States
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Orange, California, 92868, United States
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Sacramento, California, 95825, United States
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San Francisco, California, 94115, United States
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San Francisco, California, 94118, United States
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Santa Clara, California, 95051, United States
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Walnut Creek, California, 94596, United States
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Newark, Delaware, 19718, United States
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Washington D.C., District of Columbia, 20010, United States
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Gainesville, Florida, 32610, United States
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Hollywood, Florida, 33012, United States
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Jacksonville, Florida, 32207, United States
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Jacksonville, Florida, 32209, United States
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Miami, Florida, 33155, United States
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Miami, Florida, 33176, United States
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Plantation, Florida, 33317, United States
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Tampa, Florida, 33606, United States
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Atlanta, Georgia, 30342, United States
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Augusta, Georgia, 30912, United States
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Honolulu, Hawaii, 96826, United States
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Evanston, Illinois, 60201, United States
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Park Ridge, Illinois, 60068, United States
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Indianapolis, Indiana, 46260, United States
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South Bend, Indiana, 46601, United States
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Wichita, Kansas, 67214, United States
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Baltimore, Maryland, 21201, United States
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Baltimore, Maryland, 21210, United States
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Detroit, Michigan, 48201, United States
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Detroit, Michigan, 48202, United States
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Detroit, Michigan, 48236, United States
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Flint, Michigan, 48503, United States
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Grand Rapids, Michigan, 49503, United States
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Lansing, Michigan, 48912, United States
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Royal Oak, Michigan, 48073, United States
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Duluth, Minnesota, 55805, United States
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Jackson, Mississippi, 39216, United States
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St Louis, Missouri, 63141, United States
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Camden, New Jersey, 08103, United States
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Newark, New Jersey, 07103, United States
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Voorhees Township, New Jersey, 08043, United States
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Albany, New York, 12208, United States
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Manhasset, New York, 11030, United States
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Mineola, New York, 11501, United States
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New Hyde Park, New York, 11040, United States
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Syracuse, New York, 13210, United States
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The Bronx, New York, 10804, United States
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Valhalla, New York, 10595, United States
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Charlotte, North Carolina, 28204, United States
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Charlotte, North Carolina, 28232, United States
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Greenville, North Carolina, 27835, United States
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Raleigh, North Carolina, 27610, United States
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Akron, Ohio, 44308, United States
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Cincinnati, Ohio, 45219, United States
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Columbus, Ohio, 43214, United States
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Dayton, Ohio, 45409, United States
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Toledo, Ohio, 43608, United States
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Youngstown, Ohio, 44501, United States
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Bryn Mawr, Pennsylvania, 19010, United States
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Philadelphia, Pennsylvania, 19102, United States
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Philadelphia, Pennsylvania, 19107, United States
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Pittsburgh, Pennsylvania, 15224, United States
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Wynnewood, Pennsylvania, 19096, United States
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Providence, Rhode Island, 02905, United States
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Greenville, South Carolina, 29605, United States
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Memphis, Tennessee, 38120, United States
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Dallas, Texas, 75246, United States
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Houston, Texas, 77030, United States
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San Antonio, Texas, 78229, United States
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Temple, Texas, 76508, United States
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Ogden, Utah, 84403, United States
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Provo, Utah, 84604, United States
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Salt Lake City, Utah, 84113, United States
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Charlottesville, Virginia, 22908, United States
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Spokane, Washington, 99204, United States
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Morgantown, West Virginia, 26506, United States
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New Westminster, British Columbia, V3L 3 W7, Canada
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Vancouver, British Columbia, V6H 3V4, Canada
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Victoria, British Columbia, V8Z 6R5, Canada
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Halifax, Nova Scotia, B3K 6R8, Canada
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Kingston, Ontario, K7L 2V7, Canada
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Windsor, Ontario, N8W 1L9, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Saskatoon, Saskatchewan, S7N 0W8, Canada
Related Publications (1)
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 INH-A21 for the prevention of nosocomial staphylococcal bloodstream infection in premature infants. J Pediatr. 2007 Sep;151(3):260-5, 265.e1. doi: 10.1016/j.jpeds.2007.04.060. Epub 2007 Jul 24.
PMID: 17719934DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Seth V. Hetherington, MD
Inhibitex
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 6, 2005
First Posted
June 7, 2005
Study Start
May 1, 2004
Primary Completion
June 1, 2006
Study Completion
June 1, 2006
Last Updated
August 2, 2012
Record last verified: 2012-07