A randomized study of a monoclonal antibody (pagibaximab) to prevent staphylococcal sepsis
LE Weisman, HM Thackray, RH Steinhorn… - …, 2011 - publications.aap.org
BACKGROUND: Pagibaximab, a human chimeric monoclonal antibody developed against
lipoteichoic acid, was effective against staphylococci preclinically and seemed safe and well
tolerated in phase 1 studies. OBJECTIVE: To evaluate the clinical activity, pharmacokinetics,
safety, and tolerability of weekly pagibaximab versus placebo infusions in very low birth
weight neonates. PATIENTS AND METHODS: A phase 2, randomized, double-blind,
placebo-controlled study was conducted at 10 NICUs. Patients with a birth weight of 700 to …
lipoteichoic acid, was effective against staphylococci preclinically and seemed safe and well
tolerated in phase 1 studies. OBJECTIVE: To evaluate the clinical activity, pharmacokinetics,
safety, and tolerability of weekly pagibaximab versus placebo infusions in very low birth
weight neonates. PATIENTS AND METHODS: A phase 2, randomized, double-blind,
placebo-controlled study was conducted at 10 NICUs. Patients with a birth weight of 700 to …