Bacterial Infection, Ureaplasma
Conditions
Keywords
Bacterial infection, Azithromycin
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.
Interventions
DRUGAzithromycin
Sponsors
Pediatric Pharmacology Research Units Network
Children's Hospital of Michigan
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 30 Days
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United States
Outcome results
None listed