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NCT00734500 · ClinicalTrials.gov registry record · Phase 1
Anidulafungin PK in Infants and Toddlers
A Phase 1 study, sponsored by Michael Cohen-Wolkowiez.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT00734500 is a Phase 1 study that has completed, run by Michael Cohen-Wolkowiez. The registered enrollment target is 15 participants.
The verdict
NCT00734500, a Phase 1 study, has completed, sponsored by Michael Cohen-Wolkowiez.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This is a prospective, open-label, single center, pharmacokinetic study of anidulafungin in infants and toddlers less than 24 months of age with suspected serious infection. There will be up to 24 subjects enrolled; each will receive anidulafungin. Patients will receive anidulafungin 3 mg/kg loading dose on day 1 of study and will receive 1.5 mg/kg every 24 hours on study days 2-5.Plasma pharmacokinetics will be evaluated using a limited sampling scheme. We hypothesize that the PK parameters of anidulafungin will not differ from those observed in older children and adults.
Interventions
- DRUG Anidulafungin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2008-01 |
| Est. Completion | 2010-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00734500
The ClinicalTrials.gov registry entry for NCT00734500 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Michael Cohen-Wolkowiez, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Anidulafungin is the first listed.
NCT00734500 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00734500 about?
NCT00734500 is a clinical study titled "Anidulafungin PK in Infants and Toddlers". This is a prospective, open-label, single center, pharmacokinetic study of anidulafungin in infants and toddlers less than 24 months of age with suspected serious infection. There will be up to 24 subjects enrolled; each will receive anidulafungin. Patients will receive anidulafungin 3 mg/kg loading...
What is the current status of trial NCT00734500?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2008-01. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00734500?
The interventions under investigation include: Anidulafungin (DRUG).
Who is sponsoring clinical trial NCT00734500?
This trial is sponsored by Michael Cohen-Wolkowiez, which has 5 total clinical trials registered on ClinicalTrials.gov.
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