Neonatal Staphylococcal Sepsis Clinical Trial
Official title:
Phase I/II Randomized, Double Blind, Placebo Controlled, Dose Escalation, Safety and Pharmacokinetics Study in VLBW Neonates, a Human Chimeric Anti-Staphylococcal Monoclonal Antibody for the Prevention of S. Epidermidis Infection
"Phase I/II, Randomized, Double Blind, Placebo Controlled, Dose Escalating, Safety and Pharmacokinetics Study in Very Low Birth Weight Neonates of Four Doses of BSYX-A110 for the Prevention of S. epidermidis Infection." The purpose of this study is to evaluate the safety and pharmacokinetics of escalating doses of BSYX-A110 administered on Study Days 0 and 14.
"Phase I/II, Randomized, Double Blind, Placebo Controlled, Dose Escalating, Safety and
Pharmacokinetics Study in Very Low Birth Weight Neonates of Four Doses of BSYX-A110, a Human
Chimeric Anti-Staphylococcal Monoclonal Antibody for the Prevention of S. epidermidis
Infection" will be the first study of BSYX-A110 in the target population of hospitalized,
very low birth weight infants. The purpose of this study is to evaluate the safety and
pharmacokinetics of escalating doses of BSYX-A110 administered on Study Days 0 and 14.
This will be a randomized, double blind, placebo controlled, dose escalating study of
BSYX-A110 in 48 very low birth weight neonates. The dose levels to be evaluated are 10, 30,
60 and 90 mg/kg. Each dose level will enroll 12 infants who will receive two doses of
BSYX-A110 or placebo intravenously at a ratio of 2:1 while hospitalized following birth.
Infants will be followed for 8 weeks following the first dose of BSYX-A110 or placebo. The
primary objective of this study is to evaluate safety and tolerability. The secondary
objective is to analyze the pharmacokinetics of BSYX-A110. Positive cultures obtained during
the study period will be recorded and analyzed.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention