drugset / Trial / NCT00760279
An Open Label Evaluation of the Pharmacokinetics and Safety of Single Dose Intravenous Azithromycin in Preterm Neonates
Phase 1
Completed
16 enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Children's Hospital of Michigan · collabPediatric Pharmacology Research Units Network · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2005-09
- Primary completion
- —
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azithromycin | Small molecule | 10 mg/kg | Intravenous |