Phase 1
N=32
Pharmacokinetics and Safety of Piperacillin-tazobactam in Neonates
Sepsis
Bottom Line
View on ClinicalTrials.gov: NCT00873327 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
May 2013
Primary outcome: Primary: Piperacillin Pharmacokinetics (PK) — 0.0799 L/hr/kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- piperacillin-tazobactam (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Phillip Brian Smith
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Piperacillin Pharmacokinetics (PK) |
0.0799 | — |
Summary
This is a phase I open label multi-dose study to investigate the pharmacokinetics and safety of piperacillin-tazobactam in infants =14 days postnatal age
3. >=32 weeks gestational age and =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.
Eligibility Criteria
Inclusion Criteria
- Written permission from parent or legal guardian
- 1.2 mg/dL
- Any condition which would make the subject or the caregiver, in the opinion of the investigator, unsuitable for the study
Data sourced from ClinicalTrials.gov (NCT00873327). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.