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 previous pediatric pharmacokinetic studies.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Evaluation of the Pharmacokinetics and Safety of Single Dose Intravenous Azithromycin in Preterm Neonates Pediatric Pharmacology Research Unit, Children's Hospital of Michigan|
- Safety: Patients will be monitored for clinical adverse events and have standard hematology labs drawn within 72 hours of study entry. Liver function tests, renal function tests and standard chemistries will be drawn prior to and at the end of the study.
|Study Start Date:||September 2005|
In vitro studies with azithromycin show good inhibitory activity against U. urealyticum. Pharmacokinetic studies of azithromycin in older children show better tolerance, higher tissue concentration, fewer side effects, and fewer drug interactions, when compared to erythromycin. Thus far, there have been no published data on the pharmacokinetic profile of azithromycin in neonates including low birth weight infants. However, the clinical pharmacology profile suggests a substantial therapeutic advantage of this drug in the newborn. To date, there are no data on the PK profile of IV Azithromycin from whence rational dosing can be derived.
|United States, Michigan|
|Detroit, Michigan, United States, 48201|
|United States, Ohio|
|Rainbow Babies and Children's Hospital|
|Cleveland, Ohio, United States, 44106-6010|
|Principal Investigator:||Elias Tessema, M.D.||Wayne State|
|Principal Investigator:||David Edwards, Pharm.D.||Wayne State|
|Principal Investigator:||Jacob Aranda, M.D., Ph.D.||Wayne State|