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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 is a Phase 1 study that has completed, run by Duke University. The registered enrollment target is 20 participants.
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.
Interventions
- DRUG Daptomycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2010-01 |
| Est. Completion | 2011-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00942149
The ClinicalTrials.gov registry entry for NCT00942149 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Daptomycin is the first listed.
NCT00942149 reports 0 study locations.
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.
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