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Sponsors and Collaborators: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Pediatric Pharmacology Research Unit (PPRU) Children's Hospital of Michigan |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00760279 |
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.
Condition | Intervention | Phase |
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Ureaplasma Bacterial Infection |
Drug: Azithromycin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | An Open Label Evaluation of the Pharmacokinetics and Safety of Single Dose Intravenous Azithromycin in Preterm Neonates Pediatric Pharmacology Research Unit, Children's Hospital of Michigan |
Estimated Enrollment: | 16 |
Study Start Date: | September 2005 |
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.
Ages Eligible for Study: | up to 30 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Michigan | |
Wayne State | |
Detroit, Michigan, United States, 48201 | |
United States, Ohio | |
Rainbow Babies and Children's Hospital | |
Cleveland, Ohio, United States, 44106-6010 |
Principal Investigator: | Elias Tessema, M.D. | Wayne State |
Principal Investigator: | David Edwards, Pharm.D. | Wayne State |
Principal Investigator: | Jacob Aranda, M.D., Ph.D. | Wayne State |
Study ID Numbers: | PPRU10820 |
Study First Received: | September 25, 2008 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00760279 History of Changes |
Health Authority: | United States: Federal Government |
Bacterial infection Azithromycin |
Bacterial Infections Anti-Bacterial Agents Azithromycin |
Bacterial Infections Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses |
Azithromycin Infection Pharmacologic Actions |