Research

Staph Antibody Study

Trial to Evaluate Pagibaximab in Very Low Birth Weight Neonates for the Prevention of Staphylococcal Sepsis

Protocol Description

This Phase IIb/III multi-center study examines the safety and effectiveness of the new drug, Pagibaximab, in preventing sepsis caused by staphylococcal bacteria in premature babies. Lacking the antibodies found in the blood of full-term babies, premature infants have a high chance of developing sepsis while in the hospital. More than half of the cases of sepsis in premature babies are caused by staphylococcal bacteria, or “staph.” Pagibaximab provides antibodies against staphylococcal bacteria.

Eligibility Criteria

Babies with birth weight between 600 and 1200 grams (1.3 to 2.6 pounds) and an estimated gestation age of up to 33 weeks, who are being cared for in the Neonatal Intensive Care Unit (NICU) of Magee-Womens Hospital of UPMC will be considered eligible for participation.
Boys: Gestation age up to 33 weeks
Girls: Gestation age up to 33 weeks

Requirements
The premature babies who participate in this study will receive 6 doses of either the study drug or 6 doses of a placebo within their first 23 days of life. Babies will be closely monitored for effects of the study drug for about 50 days after the first dose is given.
Visits: Requires admission to NICU
Duration: 50 days

Status: Open for Enrollment

Source (s) of Support
Biosynexus

Additional Resources
Study description at National Institutes of Health