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NCT01169402 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics/Pharmacodynamics (PK/PD) of Fluconazole in Children on Extracorporeal Membrane Oxygenation (ECMO)
A Phase 1 study of Fungal Infection and Cardiopulmonary Arrest, sponsored by Michael Cohen-Wolkowiez.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT01169402 is a Phase 1 study of Fungal Infection and Cardiopulmonary Arrest that has completed, run by Michael Cohen-Wolkowiez. The registered enrollment target is 21 participants, below the 159-participant average among 6 other Fungal Infection trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01169402, a Phase 1 study of Fungal Infection and Cardiopulmonary Arrest, has completed, sponsored by Michael Cohen-Wolkowiez.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
Extracorporeal membrane oxygenation (ECMO) is a form of heart-lung bypass used to support children who suffer heart or lung failure until whatever illness caused that failure can be treated and reversed. While on ECMO, children are at increased risk of infection, including fungal infection. Treatment for fungal infection includes not only antifungal medications but also removal of any large intravenous (IV) lines. Since ECMO requires large IV lines, proper treatment of fungal infections would be difficult if not impossible. The investigators believe that giving prophylactic antifungal medication to all children on ECMO may prevent fungal infections from developing in the first place. Fluconazole is an antifungal medication that works well against the most common fungal infections and has been shown to be safe in children. Unfortunately, the ECMO machine has the potential to significantly alter the drug levels of medications so the investigators do not know the proper dose of Fluconazole to give children on ECMO. Standard dosing of fluconazole is 12mg per kilogram of body weight given intravenously once daily. Based on preliminary data and modeling from other studies, the investigators think 25mg per kilogram given once weekly will achieve proper drug levels to prevent fungal infections. The investigators have obtained FDA approval to give this dose of fluconazole to children on ECMO who are enrolled in the study. Blood samples will be collected at specific times around the first and second fluconazole doses to describe the PK and drug extraction by the ECMO circuit.
Conditions Studied
Interventions
- DRUG Fluconazole
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2010-07 |
| Est. Completion | 2013-02-20 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01169402
The ClinicalTrials.gov registry entry for NCT01169402 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 159-participant average among 6 other Fungal Infection trials with a reported enrollment target (87% lower). The listed sponsor is Michael Cohen-Wolkowiez, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Fungal Infection appearing as the primary indexed condition, and to 1 intervention - of which Fluconazole is the first listed.
NCT01169402 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT01169402 about?
NCT01169402 is a clinical study titled "Pharmacokinetics/Pharmacodynamics (PK/PD) of Fluconazole in Children on Extracorporeal Membrane Oxygenation (ECMO)". Extracorporeal membrane oxygenation (ECMO) is a form of heart-lung bypass used to support children who suffer heart or lung failure until whatever illness caused that failure can be treated and reversed. While on ECMO, children are at increased risk of infection, including fungal infection. Treatmen...
What is the current status of trial NCT01169402?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2010-07. Estimated completion is 2013-02-20.
What conditions does trial NCT01169402 study?
This clinical trial studies the following conditions: Fungal Infection, Cardiopulmonary Arrest.
What interventions are being tested in trial NCT01169402?
The interventions under investigation include: Fluconazole (DRUG).
Who is sponsoring clinical trial NCT01169402?
This trial is sponsored by Michael Cohen-Wolkowiez, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01169402 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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