Status:
COMPLETED
Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight Neonates for Prevention of Staphylococcal Sepsis
Lead Sponsor:
Biosynexus Incorporated
Conditions:
Staphylococcal Sepsis
Eligibility:
All Genders
Up to 48 years
Phase:
PHASE2
PHASE3
Brief Summary
Evaluate the safety, PK and efficacy comparing Pagibaximab Injection to placebo in preventing staphylococcal sepsis in very low birth weight infants. 1550 infants will be enrolled prior to 48 hours of...
Detailed Description
Phase 2b/3, randomized, double-blind, multicenter, placebo-controlled study evaluating the safety, efficacy and pharmacokinetics (PK) of pagibaximab (100 mg/kg/dose) in comparison to placebo for the p...
Eligibility Criteria
Inclusion
- In-patient at a Neonatal Intensive Care Unit (NICU)
- Informed consent obtained from the legally authorized representative
- Less than 48 hours old at the time of first infusion
- Birth weight between 600 grams and 1200 grams
- Estimated gestation age ≤33 weeks
- For multiple gestations, twins may be enrolled if they each meet the entry criteria. They will both be assigned to the same treatment group.
Exclusion
- Infants with history of a hypersensitivity or severe vasomotor reaction to any antibody preparation.
- Infants with proven staphylococcal infection prior to randomization.
- Infants with a concomitant infection or other medical condition, whose participation, in the opinion of the Investigator and/or medical advisor, may create an unacceptable additional risk.
- Immunodeficiency other than due to prematurity.
- Currently receiving, recently received, or planned to receive other investigational agents that could interfere with conduct or results of this study.
- Severe congenital or chromosomal anomaly that would limit life expectancy or required corrective measures during the period of this study
- Uncontrolled seizures
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
1579 Patients enrolled
Trial Details
Trial ID
NCT00646399
Start Date
March 1 2009
End Date
May 1 2011
Last Update
October 24 2011
Active Locations (1)
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1
Biosynexus Incorporated
Gaithersburg, Maryland, United States, 20877