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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: Clinical Trial Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Blood samples from the above time points will be analyzed to study the bodily absorption, distribution, metabolism, and excretion of micafungin
Interventions
- DRUG Micafungin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2014-01 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
Why NCT02057289 stopped before completion
NCT02057289 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Micafungin is the first listed.
NCT02057289 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02057289's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 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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