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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00760279
Other study ID # PPRU10820
Secondary ID
Status Completed
Phase Phase 1
First received September 25, 2008
Last updated September 25, 2008
Start date September 2005

Study information

Verified date September 2008
Source Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 30 Days
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Azithromycin


Locations

Country Name City State
United States Rainbow Babies and Children's Hospital Cleveland Ohio
United States Wayne State Detroit Michigan

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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