Conditions: Staphylococcal Sepsis
Keywords: Staphylococcal Coagulase Negative Staphylococcus Monoclonal antibodies Very Low Birth Weight Infants Prophylaxis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1579
Healthy volunteers: yes

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 life and will be randomized 1:1 to receive active drug or placebo on study days 0, 1, 2, 9, 16, and 23.

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 prevention of staphylococcal sepsis in VLBW infants (600 -1200 grams). Subjects monitored for treatment related adverse events and tolerability to infusion of study drug. Neonatal sepsis will be assessed in the presence of clinical signs and symptoms and one blood culture positive for S. aureus or two blood cultures positive for Coagulase Negative Staphylococci (CoNS). The study period will be 35 days after the first dose or until, death, discharge, or transfer, whichever occurs first.

Arms:
arm 1: Phosphate Buffered Saline arm 2: Pagibaximab at 100 mg/kg intravenously at Days 0, 1, 2, 9, 16 and 23.

Interventions: intervention 1: Placebo intervention 2: Pagibaximab 50 mg/mL
Intervention descriptions: intervention 1: Phosphate Buffered Saline on Days 0, 1, 2, 9, 16 and 23. intervention 2: Pagibaximab 100 mg/kg dosed on Days 0, 1, 2, 9, 16 and 23

Protocol document: