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NCT00942084 · ClinicalTrials.gov registry record · Phase 1
A Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants (PTN_Acyclo)
A Phase 1 study, sponsored by Phillip Brian Smith.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT00942084: Completed Phase 1 study, sponsored by Phillip Brian Smith.
NCT00942084 is a Phase 1 study that has completed, run by Phillip Brian Smith. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00942084, a Phase 1 study, has completed, sponsored by Phillip Brian Smith.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study 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.
Primary Outcome
Timeframe: Version 1:0-5 min,2-4 hrs,6-8 hrs post doses 1 and 5-15; prior to doses 5-15 Version 2:0-15 min post doses 1 and 5-15; within 30 min prior to doses 2 and 5-15; 2-3 hrs post doses 5-15; 15-18 hrs post last dose
Interventions
- DRUG Acyclovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-06 |
| Phase | Phase 1 |
What the finished NCT00942084 record still lists
NCT00942084 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 1 intervention - of which Acyclovir is the first listed.
NCT00942084 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00942084 about?
NCT00942084 is a clinical study titled "A Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants (PTN_Acyclo)". 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 ...
What is the current status of trial NCT00942084?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2011-09. Estimated completion is 2012-06.
What interventions are being tested in trial NCT00942084?
The interventions under investigation include: Acyclovir (DRUG).
Who is sponsoring clinical trial NCT00942084?
This trial is sponsored by Phillip Brian Smith, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00942084's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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