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NCT00760279 · ClinicalTrials.gov registry record · Phase 1
An Open Label Evaluation of the Pharmacokinetics and Safety of Single Dose Intravenous Azithromycin in Preterm Neonates
A Phase 1 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT00760279 is a Phase 1 study that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 16 participants.
The verdict
NCT00760279, a Phase 1 study, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of IV azithromycin in preterm neonates and confirm that the pharmacokinetics of azithromycin is similar in the 24-\<32 week and 32-\<37 week neonate. The dose of 10 mg/kg has been chosen on the basis of previous pediatric pharmacokinetic studies.
Interventions
- DRUG Azithromycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2005-09 |
| Phase | Phase 1 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00760279
The ClinicalTrials.gov registry entry for NCT00760279 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Azithromycin is the first listed.
NCT00760279 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00760279 about?
NCT00760279 is a clinical study titled "An Open Label Evaluation of the Pharmacokinetics and Safety of Single Dose Intravenous Azithromycin in Preterm Neonates". The purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of IV azithromycin in preterm neonates and confirm that the pharmacokinetics of azithromycin is similar in the 24-\<32 week and 32-\<37 week neonate. The dose of 10 mg/kg has been chosen on the basis of previou...
What is the current status of trial NCT00760279?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2005-09.
What interventions are being tested in trial NCT00760279?
The interventions under investigation include: Azithromycin (DRUG).
Who is sponsoring clinical trial NCT00760279?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
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