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

Primary Purpose

Nosocomial Infections, Sepsis, Staphylococcal Infections

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Veronate
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nosocomial Infections focused on measuring late onset sepsis, premature infants, staphylococcus, candida, prevention

Eligibility Criteria

3 Days - 5 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

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

Full Information

First Posted
June 6, 2005
Last Updated
July 26, 2012
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00113191
Brief Title
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

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nosocomial Infections, Sepsis, Staphylococcal Infections, Candidemia
Keywords
late onset sepsis, premature infants, staphylococcus, candida, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
2000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Veronate
Primary Outcome Measure Information:
Title
To assess the efficacy of Veronate® compared to placebo in preventing nosocomial S. aureus sepsis in premature infants
Title
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 Measure Information:
Title
To compare the proportions of infants with nosocomial coagulase negative staphylococcus (CoNS) sepsis between premature infants treated with Veronate® versus placebo
Title
To compare the proportions of infants with all nosocomial staphylococcal sepsis between premature infants treated with Veronate® versus placebo
Title
To compare the proportions of infants with nosocomial candidemia between premature infants treated with Veronate® versus placebo
Title
To compare mortality between premature infants treated with Veronate® versus placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Days
Maximum Age & Unit of Time
5 Days
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seth V. Hetherington, MD
Organizational Affiliation
Inhibitex
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
City
Hayward
State/Province
California
ZIP/Postal Code
94545
Country
United States
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
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United States
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94596
Country
United States
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
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United States
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33012
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United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
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United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
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United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
City
Plantation
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
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United States
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Augusta
State/Province
Georgia
ZIP/Postal Code
30912
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United States
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
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United States
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
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Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
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United States
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Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
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United States
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South Bend
State/Province
Indiana
ZIP/Postal Code
46601
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United States
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Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
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United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21210
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United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
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United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
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United States
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Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
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United States
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
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United States
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Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
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United States
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Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
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United States
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
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United States
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St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
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United States
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
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United States
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
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United States
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12208
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United States
City
Bronx
State/Province
New York
ZIP/Postal Code
10804
Country
United States
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232
Country
United States
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27835
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United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
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United States
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
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United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
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United States
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
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United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
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United States
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44501
Country
United States
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3 W7
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8Z 6R5
Country
Canada
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1L9
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17719934
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.
Results Reference
derived

Learn more about this trial

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

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