Clinical trial NCT00113191: Safety and Efficacy of Veronate® Versus Placebo in Preventing Nosocomial Staphylococcal Sepsis in Premature Infants
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nosocomial Infections
Sepsis
Staphylococcal Infections
Candidemia
Keywords: late onset sepsis
premature infants
staphylococcus
candida
prevention
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-06-07
Enrollment: 2000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: To assess the efficacy of Veronate® compared to placebo in preventing nosocomial S. aureus sepsis in premature infants
measure: 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:
measure: To compare the proportions of infants with nosocomial coagulase negative staphylococcus (CoNS) sepsis between premature infants treated with Veronate® versus placebo
measure: To compare the proportions of infants with all nosocomial staphylococcal sepsis between premature infants treated with Veronate® versus placebo
measure: To compare the proportions of infants with nosocomial candidemia between premature infants treated with Veronate® versus placebo
measure: To compare mortality between premature infants treated with Veronate® versus placebo
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Anchorage
country: United States
state: Alaska
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Hayward
country: United States
state: California
city: Loma Linda
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Oakland
country: United States
state: California
city: Oakland
country: United States
state: California
city: Orange
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Francisco
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Santa Clara
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Newark
country: United States
state: Delaware
city: Washington
country: United States
state: District of Columbia
city: Gainesville
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Evanston
country: United States
state: Illinois
city: Park Ridge
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: South Bend
country: United States
state: Indiana
city: Wichita
country: United States
state: Kansas
city: Baltimore
country: United States
state: Maryland
city: Baltimore
country: United States
state: Maryland
city: Detroit
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Flint
country: United States
state: Michigan
city: Grand Rapids
country: United States
state: Michigan
city: Lansing
country: United States
state: Michigan
city: Royal Oak
country: United States
state: Michigan
city: Duluth
country: United States
state: Minnesota
city: Jackson
country: United States
state: Mississippi
city: St. Louis
country: United States
state: Missouri
city: Camden
country: United States
state: New Jersey
city: Newark
country: United States
state: New Jersey
city: Voorhees
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: Bronx
country: United States
state: New York
city: Manhasset
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: New Hyde Park
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Valhalla
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Greenville
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Youngstown
country: United States
state: Ohio
city: Bryn Mawr
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Wynnewood
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Greenville
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Ogden
country: United States
state: Utah
city: Provo
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Morgantown
country: United States
state: West Virginia
city: New Westminster
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: Halifax
country: Canada
state: Nova Scotia
city: Kingston
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
Study officials:
affiliation: Inhibitex
name: Seth V. Hetherington, MD
role: STUDY_DIRECTOR
References:
citation: 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.