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NCT02057289 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetic Study of Pediatric Micafungin Prophylaxis
A Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT02057289 is a Phase 1 study that was terminated before completion, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 9 participants.
The verdict
NCT02057289, a Phase 1 study, was terminated before completion, sponsored by Children's Hospital Medical Center, Cincinnati.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
The purpose of this research study is to examine the pharmacokinetics (the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body) of micafungin when it is given at 5mg/kg dose to immunocompromised children as anti-fungal prophylaxis. These children are at high risk for developing invasive fungal disease due to their compromised immunity and associated variable degree and duration of neutropenia. Currently, children who receive micafungin are given daily or alternate day dosing. The investigators will give a ONE TIME dose of micafungin and draw PK levels up to 96 hours post-infusion. The investigators goal is to obtain comparable micafungin drug concentrations at the end of 96 hours (4 days) as compared to lower dose at every 24 hour dosing. The investigators dosing proposal is likely to be effective prophylaxis for immunocompromised patients and would broaden its applicability to larger populations.
Interventions
- DRUG Micafungin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2014-01 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02057289
The ClinicalTrials.gov registry entry for NCT02057289 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Micafungin is the first listed.
NCT02057289 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02057289 about?
NCT02057289 is a clinical study titled "A Pharmacokinetic Study of Pediatric Micafungin Prophylaxis". The purpose of this research study is to examine the pharmacokinetics (the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body) of micafungin when it is given at 5mg/kg dose to immunocompromised children as anti-fungal prophylaxis. These children are at high ris...
What is the current status of trial NCT02057289?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2014-01. Estimated completion is 2014-11.
What interventions are being tested in trial NCT02057289?
The interventions under investigation include: Micafungin (DRUG).
Who is sponsoring clinical trial NCT02057289?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
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