Status:
COMPLETED
An Open Label Evaluation of the Pharmacokinetics and Safety of Single Dose Intravenous Azithromycin in Preterm Neonates
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsors:
Pediatric Pharmacology Research Units Network
Children's Hospital of Michigan
Conditions:
Ureaplasma
Bacterial Infection
Eligibility:
All Genders
Up to 30 years
Phase:
PHASE1
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...
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, f...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00760279
Start Date
September 1 2005
Last Update
September 26 2008
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Wayne State
Detroit, Michigan, United States, 48201
2
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106-6010