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NCT01976078 · ClinicalTrials.gov registry record
Development of Voriconazole Pharmacokinetics and Metabolism in Children and Adolescents
A clinical trial of Pharmacokinetics and Voriconazole, sponsored by Children's Hospital Los Angeles.
- Completed
- Registry status
- 45
- Enrollment target
- 1
- Study location
NCT01976078: Completed study of Pharmacokinetics and Voriconazole, sponsored by Children's Hospital Los Angeles.
NCT01976078 is a study of Pharmacokinetics and Voriconazole that has completed, run by Children's Hospital Los Angeles. The registered enrollment target is 45 participants, below the 61-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (26% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01976078, a study of Pharmacokinetics and Voriconazole, has completed, sponsored by Children's Hospital Los Angeles.
- COMPLETED
- Registry status
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
The death rate in children from the invasive fungal infection called aspergillosis is more than 50%. Voriconazole is the first-line therapy for this infection. In a previous publication the investigators have shown a highly significant relationship between voriconazole plasma concentrations and survival. However, voriconazole dosing is currently poorly established, and plasma drug exposure varies between children by 400% or more, even after intravenous dosing. The objective of this study is to investigate the reasons for this variability in voriconazole pharmacokinetics (PK).In two studies, the investigators will enroll 80 children/adolescents receiving oral or intravenous voriconazole, divided by age under 2 years (n=15), and 2-18 years (n=65). From each patient the investigators will collect the following: 1) a blood sample for detection of several genetic changes known to affect drug metabolizing enzyme (DME) activity; 2) up to 9 blood samples after a voriconazole dose for measurement of voriconazole ("PK sampling"); 3) follow-up samples after each PK sampling visit if necessary to adjust the dose so that voriconazole concentrations in the blood are satisfactory (known as therapeutic drug monitoring or TDM). At the time of the voriconazole dose prior to the PK sampling, we will also give single IV or oral (corresponding to the route of voriconazole administration) low doses of esomeprazole (an antacid), midazolam (a sedative), and ranitidine (an antacid) as a cocktail to test or probe DME activity. All of these medications are used commonly in children already. The investigators will estimate DME activity or phenotype using ratios of probe drug metabolite to parent drug concentrations, while simultaneously quantifying the amount of DME genetic material (mRNA) and protein in white blood cells. The investigators will test associations between DME activity, mRNA, protein, voriconazole PK, age, sex, and degree of illness. The investigators will also use a computer pr
Primary Outcome
8 (after intravenous dosing) or 9 (after oral dosing) samples are taken after a voriconazole dose over a 12 hour timeframe.
Conditions Studied
Interventions
- DRUG Midazolam/Ranitidine/Esomeprazole
Study Locations (1)
California
- Children's Hospital Los Angeles - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2012-09 |
| Est. Completion | 2015-04-22 |
What the finished NCT01976078 record still lists
NCT01976078 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 61-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (26% lower).
The record links to 2 conditions, with Pharmacokinetics appearing as the primary indexed condition, and to 1 intervention - of which Midazolam/Ranitidine/Esomeprazole is the first listed.
NCT01976078 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01976078 about?
NCT01976078 is a clinical study titled "Development of Voriconazole Pharmacokinetics and Metabolism in Children and Adolescents". The death rate in children from the invasive fungal infection called aspergillosis is more than 50%. Voriconazole is the first-line therapy for this infection. In a previous publication the investigators have shown a highly significant relationship between voriconazole plasma concentrations and surv...
What is the current status of trial NCT01976078?
This trial is currently completed. The enrollment target is 45 participants. The study started on 2012-09. Estimated completion is 2015-04-22.
What conditions does trial NCT01976078 study?
This clinical trial studies the following conditions: Pharmacokinetics, Voriconazole.
What interventions are being tested in trial NCT01976078?
The interventions under investigation include: Midazolam/Ranitidine/Esomeprazole (DRUG).
Who is sponsoring clinical trial NCT01976078?
This trial is sponsored by Children's Hospital Los Angeles, which has 119 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01976078 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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