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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: Completed Phase 1 study, sponsored by Michael Cohen-Wolkowiez.
NCT00734500 is a Phase 1 study that has completed, run by Michael Cohen-Wolkowiez. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Area under the curve at steady state
Interventions
- DRUG Anidulafungin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2008-01 |
| Est. Completion | 2010-06 |
| Phase | Phase 1 |
What the finished NCT00734500 record still lists
NCT00734500 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which Anidulafungin is the first listed.
NCT00734500 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00734500's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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