Neonates with Enteroviral Sepsis Syndrome
CASG 106: A Double-Blind, Placebo-Controlled, Virologic Efficacy Trial of Pleconaril in the Treatment of Neonates with Enteroviral Sepsis Syndrome
Protocol ID
Protocol Description
The purpose of this study is to determine if administration of an experimental drug called pleconaril helps in treating babies with enteroviral sepsis. This research study is for infants with enteroviral sepsis who are 15 days of age or less when they get sick.
The drug we are studying is pleconaril. Pleconaril is an experimental drug that has been put into a liquid form that can be given to babies by mouth. Pleconaril works well against enteroviruses in laboratory tests and in animal studies. Standard medical care of babies with enteroviral disease is supportive care (to treat the symptoms of the disease). There is no licensed drug that works against enterovirus. Pleconaril treatment offers the possibility of fighting the virus that causes the disease. At the same time we do not know if pleconaril is safe for infants. The purpose of this study is to determine a safe and effective dose of pleconaril to help babies with this disease. Babies in the study will continue to receive standard medical care for the treatment of their symptoms.
Eligibility Criteria
Children who are sick with a severe infection (enteroviral sepsis) and their mothers
Primary Investigator(s)
- Sunil Sood, MD