Trial · NCT00942084
A Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants (PTN_Acyclo)
NCT00942084, Phase 1, Completed, Phillip Brian Smith; results first posted 2014-01-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants (PTN_Acyclo). Trials, record NCT00942084. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00942084
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants (PTN_Acyclo)
- NCT number
- NCT00942084
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 32 participants, actual
- Lead sponsor
- Phillip Brian Smith
- Conditions
- Herpes Simplex Virus, Neonatal Sepsis
- Interventions
- Acyclovir
- First posted
- 2009-07-20
- Last updated
- 2019-01-08
- Results first posted
- 2014-01-08
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clearance (CL) | V1:0-5 min,2-4 hrs,6-8 hrs post Doses 1&5-15;prior to doses 5-15; V2:0-15 min post doses 1&5-15; within 30 min prior to doses 2&5-15; 2-3 hrs post doses 5-15; 15-18 hrs post last dose | 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 |
| Primary | Volume of Distribution (V) | up to 3 days of study drug administration and 10 days of safety monitoring | |
| Primary | Half-life (T1/2) | up to 3 days of study drug administration and 10 days of safety monitoring | |
| Primary | Maximum Steady State Concentration (Cmaxss) | up to 3 dasy of study drug administration and 10 days of safety monitoring | |
| Primary | Steady State Concentration at 50% of the Dosing Interval (C50ss) | up to 3 days of study drug administration and 10 days of safety monitoring | |
| Primary | Minimum Steady State Concentration (Cminss) | up to 3 days of study drug administration and 10 days of safety monitoring |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clearance (CL) | V1:0-5 min,2-4 hrs,6-8 hrs post Doses 1&5-15;prior to doses 5-15; V2:0-15 min post doses 1&5-15; within 30 min prior to doses 2&5-15; 2-3 hrs post doses 5-15; 15-18 hrs post last dose | 32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis. | L/h/kg | MEDIAN |
| PRIMARY | Volume of Distribution (V) | up to 3 days of study drug administration and 10 days of safety monitoring | 32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis. | L/kg | MEDIAN |
| PRIMARY | Half-life (T1/2) | up to 3 days of study drug administration and 10 days of safety monitoring | 32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis. | h | MEDIAN |
| PRIMARY | Maximum Steady State Concentration (Cmaxss) | up to 3 dasy of study drug administration and 10 days of safety monitoring | 32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis. | mg/L | MEDIAN |
| PRIMARY | Steady State Concentration at 50% of the Dosing Interval (C50ss) | up to 3 days of study drug administration and 10 days of safety monitoring | 32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis. | mg/L | MEDIAN |
| PRIMARY | Minimum Steady State Concentration (Cminss) | up to 3 days of study drug administration and 10 days of safety monitoring | 32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis. | mg/L | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clearance (CL) | Acyclovir Study Design | 0.278 | Full Range 0.095 to 0.812 | L/h/kg | |
| Volume of Distribution (V) | Acyclovir Study Design | 3.34 | Full Range 0.293 to 10.85 | L/kg | |
| Half-life (T1/2) | Acyclovir Study Design | 7.07 | Full Range 1.61 to 13.2 | h | |
| Maximum Steady State Concentration (Cmaxss) | Acyclovir Study Design | 11.1 | Full Range 4.59 to 110 | mg/L | |
| Steady State Concentration at 50% of the Dosing Interval (C50ss) | Acyclovir Study Design | 6.33 | Full Range 3.38 to 65.7 | mg/L | |
| Minimum Steady State Concentration (Cminss) | Acyclovir Study Design | 4.15 | Full Range 2.19 to 39.3 | mg/L |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Acyclovir Study Enrollment | 32 | |
| Overall Study | COMPLETED | Acyclovir Study Enrollment | 30 | |
| Overall Study | NOT COMPLETED | Acyclovir Study Enrollment | 2 |
Source ClinicalTrials.gov
Adverse events31
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Haemolytic anemia | Blood and lymphatic system disorders | Acyclovir Study Design | 1 | 32 | 1 |
| other | Cardiomegaly | Cardiac disorders | Acyclovir Study Design | 1 | 32 | 1 |
| other | Atrial septal defect | Congenital, familial and genetic disorders | Acyclovir Study Design | 1 | 32 | 1 |
| other | Congenital cardiovascular anomaly | Congenital, familial and genetic disorders | Acyclovir Study Design | 7 | 32 | 7 |
| other | Nonketotic hyperglycinaemia | Congenital, familial and genetic disorders | Acyclovir Study Design | 1 | 32 | 1 |
| other | Patent ductus arteriosus | Congenital, familial and genetic disorders | Acyclovir Study Design | 3 | 32 | 3 |
| other | Ventricular septal defect | Congenital, familial and genetic disorders | Acyclovir Study Design | 1 | 32 | 1 |
| other | Adrenal insufficiency | Endocrine disorders | Acyclovir Study Design | 3 | 32 | 3 |
| other | Hyperbilirubinaemia | Hepatobiliary disorders | Acyclovir Study Design | 1 | 32 | 1 |
| other | Hyperbilirubinaemia neonatal | Hepatobiliary disorders | Acyclovir Study Design | 1 | 32 | 1 |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Acyclovir Study Design | ||
| Total, other adverse events | Acyclovir Study Design | 21 | 32 |
| Total, serious adverse events | Acyclovir Study Design | 4 | 32 |
Source ClinicalTrials.gov
Papers11
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00942084
GET https://conductscience.org/api/trials/v1/NCT00942084/events?page=2