A common group of viruses that infect humans are enteroviruses. Enteroviruses produce
illnesses in children which may range from very mild (summer colds) to severe (infections of
the brain, liver, and heart). The purpose of this study is to determine if a new drug called
pleconaril helps treat babies with enteroviral sepsis. In addition, researchers are
attempting to determine a safe and effective dose of pleconaril to help babies with this
disease. Infants who are 15 days or younger when diagnosed with enteroviral disease are
eligible for this study. Two out of 3 babies will be randomly assigned to receive Pleconaril
and the other one out of three will receive a placebo (inactive substitute). Participants
will be hospitalized while receiving study medication. Babies will receive standard treatment
care for their symptoms and will be observed for their medical progress. Participants may be
in the study for up to 2 years.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)