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

NCT ID: NCT00760279

Last Updated: 2008-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Brief Summary

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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

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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.

Conditions

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Ureaplasma Bacterial Infection

Keywords

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Bacterial infection Azithromycin

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Azithromycin

Intervention Type DRUG

Eligibility Criteria

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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.
Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pediatric Pharmacology Research Units Network

NETWORK

Sponsor Role collaborator

Children's Hospital of Michigan

OTHER

Sponsor Role collaborator

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

NIH

Sponsor Role lead

Principal Investigators

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Elias Tessema, M.D.

Role: PRINCIPAL_INVESTIGATOR

Wayne State

David Edwards, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

Wayne State

Jacob Aranda, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Wayne State

Locations

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Wayne State

Detroit, Michigan, United States

Site Status

Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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PPRU10820

Identifier Type: -

Identifier Source: org_study_id