An Open Label Evaluation of the Pharmacokinetics and Safety of Single Dose Intravenous Azithromycin in Preterm Neonates

This study has been completed.

First Received on September 25, 2008. No Changes Posted

Sponsor:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators:	Pediatric Pharmacology Research Units Network Children's Hospital of Michigan
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00760279

Purpose

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.

Condition	Intervention	Phase
Ureaplasma Bacterial Infection	Drug: Azithromycin	Phase 1

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Bacterial Infections

Drug Information available for: Azithromycin Azithromycin dihydrate Azithromycin monohydrate

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:

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.

Estimated Enrollment:	16
Study Start Date:	September 2005

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	up to 30 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

24 to 37 weeks gestational age
postnatal age 0 to 30 days
May require therapy with antibiotics/anti-infectives
Have baseline Hematology labs available (hemoglobin, hematocrit, white blood cell and differential and platelet count), which have been obtained within the previous 72 hours, as part of their standard of care
Signed informed consent by the parent or guardian

Exclusion Criteria:

Clinically significant hepatic disease (ALT or AST twice the normal value)
Clinically significant anemia (hemoglobin < 10 gm %)
Neutropenia (absolute neutrophil count < 500 cells/mm3)
Clinically significant renal disease [Creatinine clearance twice the normal value, as calculated by the Schwartz formula : Length in cms x k (a constant) / S.Cr (Values for the constant are given in Appendix 1)]
Cardiac rhythm abnormalities
Critically ill patients
Patients who are on or expected to be on the following concurrent medications carbamazepine, phenytoin, theophylline, digoxin, warfarin, ergot alkaloids, triazolam, cyclosporine, terfenadine, hexobarbital and antacids.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760279

Locations

United States, Michigan
Wayne State
Detroit, Michigan, United States, 48201
United States, Ohio
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106-6010

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Pediatric Pharmacology Research Units Network

Children's Hospital of Michigan

Investigators

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

More Information

Additional Information:

Pediatric Pharmacology Research Unit This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00760279 History of Changes
Other Study ID Numbers:	PPRU10820
Study First Received:	September 25, 2008
Last Updated:	September 25, 2008
Health Authority:	United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Bacterial infection
Azithromycin

Additional relevant MeSH terms:

Bacterial Infections
Azithromycin
Anti-Bacterial Agents

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2012