At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pharmacokinetics and Safety of Piperacillin-tazobactam in Neonates
In Brief
A Phase 1 clinical trial evaluating piperacillin-tazobactam for Sepsis. Completed, enrolled 32 participants across 4 sites.
Detailed Summary
This is a phase I open label multi-dose study to investigate the pharmacokinetics and safety of piperacillin-tazobactam in infants \< 61 days of age with suspected sepsis. There will be four cohorts of 8 infants each: 1. \< 32 weeks gestational age (GA) and \< 14 days postnatal age (PNA) 2. \< 32 weeks gestational age and \>=14 days postnatal age 3. \>=32 weeks gestational age and \< 14 days postnatal age 4. \>=32 weeks gestational age and \>=14 days postnatal age. The study requires administration of 6 doses of study drug along with other antimicrobials per standard of care followed by 1 week of safety monitoring. Four 200 µL pK samples will be obtained at steady state. The risks are reasonable vs. the benefits and have been minimized appropriately. There may be benefit to the subjects (administration of broad spectrum empirical antimicrobial therapy), and information from the study may benefit a large number of other infants in whom the drug is currently being administered despite the lack of PK data in this population.
Study Details
Timeline
Interventions
6 doses intravenously at the following doses: Infants \<32 weeks gestation at birth \< 14 days PNA 100 mg/kg Q8 ≥ 14 weeks PNA 100 mg/kg Q6 Infants ≥32 weeks gestation at birth \< 14 days PNA 100 mg/kg Q6 ≥ 14 days PNA 100 mg/kg Q6