Safety and Efficacy of Veronate® Versus Placebo in Preventing Nosocomial Staphylococcal Sepsis in Premature Infants
NCT ID: NCT00113191
Last Updated: 2012-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2000 participants
INTERVENTIONAL
2004-05-31
2006-06-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
DOUBLE
Interventions
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Veronate
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
3 Days
5 Days
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Principal Investigators
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Seth V. Hetherington, MD
Role: STUDY_DIRECTOR
Inhibitex
Locations
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Birmingham, Alabama, United States
Mobile, Alabama, United States
Anchorage, Alaska, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Hayward, California, United States
Loma Linda, California, United States
Long Beach, California, United States
Oakland, California, United States
Oakland, California, United States
Orange, California, United States
Sacramento, California, United States
San Francisco, California, United States
San Francisco, California, United States
Santa Clara, California, United States
Walnut Creek, California, United States
Newark, Delaware, United States
Washington D.C., District of Columbia, United States
Gainesville, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Plantation, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Honolulu, Hawaii, United States
Evanston, Illinois, United States
Park Ridge, Illinois, United States
Indianapolis, Indiana, United States
South Bend, Indiana, United States
Wichita, Kansas, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Detroit, Michigan, United States
Detroit, Michigan, United States
Detroit, Michigan, United States
Flint, Michigan, United States
Grand Rapids, Michigan, United States
Lansing, Michigan, United States
Royal Oak, Michigan, United States
Duluth, Minnesota, United States
Jackson, Mississippi, United States
St Louis, Missouri, United States
Camden, New Jersey, United States
Newark, New Jersey, United States
Voorhees Township, New Jersey, United States
Albany, New York, United States
Manhasset, New York, United States
Mineola, New York, United States
New Hyde Park, New York, United States
Syracuse, New York, United States
The Bronx, New York, United States
Valhalla, New York, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Greenville, North Carolina, United States
Raleigh, North Carolina, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Toledo, Ohio, United States
Youngstown, Ohio, United States
Bryn Mawr, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Wynnewood, Pennsylvania, United States
Providence, Rhode Island, United States
Greenville, South Carolina, United States
Memphis, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Temple, Texas, United States
Ogden, Utah, United States
Provo, Utah, United States
Salt Lake City, Utah, United States
Charlottesville, Virginia, United States
Spokane, Washington, United States
Morgantown, West Virginia, United States
New Westminster, British Columbia, Canada
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Halifax, Nova Scotia, Canada
Kingston, Ontario, Canada
Windsor, Ontario, Canada
Montreal, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Countries
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References
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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.
Other Identifiers
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IgG-CL-006
Identifier Type: -
Identifier Source: org_study_id