A Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants (PTN_Acyclo)
Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
Summary
Acyclovir is a drug used to treat herpes simplex virus (HSV) infections in babies.
Appropriate dosing of acyclovir is known for adults and children but acyclovir has not been
adequately studied in full-term or premature neonates. HSV is a very serious infection in
babies <6 months of age and often results in death or profound mental retardation. HSV leads
to profound mental retardation in young infants because the virus attacks the central nervous
system.
The investigators hypothesize that the currently recommended dose of acyclovir is inadequate
to produce adequate blood levels to combat herpes simplex infection. The investigators
propose to study acyclovir levels in the blood of babies who are placed on acyclovir to treat
a suspected HSV infection. This will allow them to determine the appropriate dose in
premature infants. This is an unmet public health need because it is likely that the drug
behaves differently in premature infants than it does in term infants and older children.
Premature babies have more body water and less body tissue. Their kidneys are more immature
and do not function as well as full term infants. Premature neonates are also at the greatest
risk from herpes infection because they have poorly functioning immature immune systems.
Early and appropriate treatment with acyclovir has resulted in improved outcome in term
infants.
Phase:
Phase 1
Details
Lead Sponsor:
Phillip Brian Smith
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)