A Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants (PTN_Acyclo)

ClinicalTrials.gov ID: NCT00942084

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Official title

An Open Label Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT00942084
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Phillip Brian Smith; Other
Enrollment: 32 participants

Conditions and interventions

Conditions

Interventions

Acyclovir Drug

Drug

Eligibility (public fields only)

Age range: Up to 45 Days
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 2011 (Type not available)
Primary completion: Jun 2012 (Actual)
Completion: Jun 2012 (Actual)
Last update posted: Jan 8, 2019

2011 – 2012

United States locations

U.S. sites: 3
U.S. states: 3
U.S. cities: 3

Facility	City	State	ZIP	Site status
Wesely Medical Center	Wichita	Kansas	67214-4976	—
Tulane School of Medicine	New Orleans	Louisiana	70112	—
Duke University	Durham	North Carolina	27713	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00942084, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jan 8, 2019 · Synced Nov 12, 2026