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Phase 3 Trial for Veronate Initiated
The primary endpoint of the trial is to demonstrate efficacy in the prevention of hospital-associated infections due to Staphylococcus aureus (S. aureus) in very low birth weight infants that weigh between 500 and 1,250 grams at birth. Secondary end points of the trial include a reduction in the frequency of hospital-associated infections due to Candida species (fungus) and Coagulase-negative staphylococci, and a reduction in the mortality rate among these high-risk infants.
"We are pleased to have started this pivotal trial ahead of schedule and are encouraged by the receptivity we are experiencing within the neonatology community," stated William D. Johnston, president and chief executive officer. "To date, we have initiated 14 sites and have approximately 70 other neonatology intensive care units (NICU) engaged in various stages of the initiation process. We believe this high level of enthusiasm for our Phase III trial is a result of the strength of the data we observed in our Phase II study and the neonatologists' recognition of this significant, unmet clinical need."
"The prevention of hospital-associated infections is a major challenge to the care of very premature infants, many whom must remain in the neonatal intensive care unit for months," commented Whit Walker, M.D., FAAP; Clinical Assistant Professor, Division of Neonatology, Greenville Hospital System a primary investigator for the study. He added, "New strategies to reduce the health care burden of staphylococcal and Candida infections in these infants are urgently needed."
While in the neonatal intensive care unit, up to one-half of very low birth weight infants that weigh less than 1,250 grams at birth will acquire an infection, the majority of which are caused by staphylococcal and Candida organisms. In addition to increasing their mortality rate, hospital- associated infections have also been shown to extend a very low birth weight infant's already lengthy stay in the neonatal intensive care unit by an average of 19 days.
Source: Inhibitex, Inc.