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NCT00942149 · ClinicalTrials.gov registry record · Phase 1
An Open Label Study to Describe the Pharmacokinetics of Daptomycin in Infants
A Phase 1 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT00942149: Completed Phase 1 study, sponsored by Duke University.
NCT00942149 is a Phase 1 study that has completed, run by Duke University. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00942149, a Phase 1 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This is a safety and pharmacokinetic study of single-dose daptomycin in infants \> 48 hours and \< 120 days of age with suspected systemic infections. The investigators will enroll a total of 24 infants in 4 gestational age/postnatal age cohorts. Interim analyses will be performed after 3 infants are enrolled in each cohort. The investigators anticipate that 6 mg/kg of daptomycin will yield an AUC \<740 mch\*hr/mL.
Primary Outcome
Area under the curve
Interventions
- DRUG Daptomycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2010-01 |
| Est. Completion | 2011-12 |
| Phase | Phase 1 |
What the finished NCT00942149 record still lists
NCT00942149 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which Daptomycin is the first listed.
NCT00942149 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00942149 about?
NCT00942149 is a clinical study titled "An Open Label Study to Describe the Pharmacokinetics of Daptomycin in Infants". This is a safety and pharmacokinetic study of single-dose daptomycin in infants \> 48 hours and \< 120 days of age with suspected systemic infections. The investigators will enroll a total of 24 infants in 4 gestational age/postnatal age cohorts. Interim analyses will be performed after 3 infants ar...
What is the current status of trial NCT00942149?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2010-01. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00942149?
The interventions under investigation include: Daptomycin (DRUG).
Who is sponsoring clinical trial NCT00942149?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00942149's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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