Pharmacokinetics and Safety of Piperacillin-tazobactam in Neonates
Status:
Completed
Trial end date:
2010-07-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Phillip Brian Smith
Treatments:
Penicillanic Acid Piperacillin Piperacillin, Tazobactam Drug Combination Tazobactam