NCT00760279

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2008

Completed
Last Updated

September 26, 2008

Status Verified

September 1, 2008

First QC Date

September 25, 2008

Last Update Submit

September 25, 2008

Conditions

UreaplasmaBacterial Infection

Keywords

Bacterial infectionAzithromycin

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

AzithromycinDRUG

Eligibility Criteria

AgeUp to 30 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Wayne State

Detroit, Michigan, 48201, United States

Location

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106-6010, United States

Location

MeSH Terms

Conditions

Bacterial Infections

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Elias Tessema, M.D.

    Wayne State

    PRINCIPAL INVESTIGATOR

  • David Edwards, Pharm.D.

    Wayne State

    PRINCIPAL INVESTIGATOR

  • Jacob Aranda, M.D., Ph.D.

    Wayne State

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 25, 2008

First Posted

September 26, 2008

Study Start

September 1, 2005

Last Updated

September 26, 2008

Record last verified: 2008-09

Locations

US(2)