Status:
COMPLETED
Safety and Efficacy of Veronate® Versus Placebo in Preventing Nosocomial Staphylococcal Sepsis in Premature Infants
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Nosocomial Infections
Sepsis
Eligibility:
All Genders
3-5 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT00113191
Start Date
May 1 2004
End Date
June 1 2006
Last Update
August 2 2012
Active Locations (93)
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1
Birmingham, Alabama, United States, 35233
2
Mobile, Alabama, United States, 36604
3
Anchorage, Alaska, United States, 99508
4
Phoenix, Arizona, United States, 85013