Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators:
Children's Hospital of Michigan
Pediatric Pharmacology Research Units Network
Treatments:
Azithromycin
Criteria
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.