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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.
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
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
Biosynexus
Study description at National Institutes of Health
Toby Debra Yanowitz, MD
Toby Debra Yanowitz, MD 412-692-5030
Children's Hospital's main campus is located in the Lawrenceville neighborhood. Our main hospital address is:
UPMC Children’s Hospital of Pittsburgh One Children’s Hospital Way 4401 Penn Ave. Pittsburgh, PA 15224
In addition to the main hospital, Children's has many convenient locations in other neighborhoods throughout the greater Pittsburgh region.
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