Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight Neonates for Prevention of Staphylococcal Sepsis
Status:
Completed
Trial end date:
2011-05-01
Target enrollment:
Participant gender:
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 life and will be randomized 1:1 to receive active drug or placebo on study
days 0, 1, 2, 9, 16, and 23.