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

Primary Purpose

Ureaplasma, Bacterial Infection

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Azithromycin
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ureaplasma focused on measuring Bacterial infection, Azithromycin

Eligibility Criteria

undefined - 30 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 24 to 37 weeks gestational age
  2. postnatal age 0 to 30 days
  3. May require therapy with antibiotics/anti-infectives
  4. 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
  5. Signed informed consent by the parent or guardian

Exclusion Criteria:

  1. Clinically significant hepatic disease (ALT or AST twice the normal value)
  2. Clinically significant anemia (hemoglobin < 10 gm %)
  3. Neutropenia (absolute neutrophil count < 500 cells/mm3)
  4. 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)]
  5. Cardiac rhythm abnormalities
  6. Critically ill patients
  7. 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.

Sites / Locations

  • Wayne State
  • Rainbow Babies and Children's Hospital

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
September 25, 2008
Last Updated
September 25, 2008
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
Pediatric Pharmacology Research Units Network, Children's Hospital of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT00760279
Brief Title
An Open Label Evaluation of the Pharmacokinetics and Safety of Single Dose Intravenous Azithromycin in Preterm Neonates
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
Pediatric Pharmacology Research Units Network, Children's Hospital of Michigan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureaplasma, Bacterial Infection
Keywords
Bacterial infection, Azithromycin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Azithromycin
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elias Tessema, M.D.
Organizational Affiliation
Wayne State
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Edwards, Pharm.D.
Organizational Affiliation
Wayne State
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacob Aranda, M.D., Ph.D.
Organizational Affiliation
Wayne State
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wayne State
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-6010
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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