This study is evaluating the safety and pharmacokinetics (PK) of intravenous acyclovir in premature infants with suspected systemic infection. Twenty infants, ≤34 weeks gestation, participated in the study for up to 13 days at two centers. Because the current acyclovir package insert does not provide dosing guidance in this vulnerable population, the Pediatric Trials Network hopes to generate PK and safety data to guide dosing of acyclovir in premature infants.

SUMMARY

Infants have immature immune systems and are at high risk for serious infections caused by bacteria, viruses, or fungi. Because these infections can have severe consequences, doctors frequently give antimicrobial therapy to infants who are suspected of having an infection, even without definitively knowing the source of infection.

Acyclovir is approved by the U.S. Food and Drug Administration for herpes simplex virus (HSV) infections in infants. HSV is a very serious infection in this vulnerable group, often resulting in death or profound mental retardation. To date, appropriate dosing of acyclovir has not been adequately studied in premature infants, meaning that doctors must make educated guesses about the dosing of this potentially life-saving drug.

In this study, 20 premature infants (<35 weeks gestation at birth and <45 days of age) with suspected HSV infections were enrolled. We administered acyclovir to the infants and are determining the levels of acyclovir in each. This will allow us to determine the appropriate dose of acyclovir in this understudied population.

An Open-label Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants from DCRI.

Acyclovir PK study is complete

PTN acyclovir trial locks its database

The PTN acyclovir trial completes enrollment