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NCT00873327 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics and Safety of Piperacillin-tazobactam in Neonates
A Phase 1 study, sponsored by Phillip Brian Smith.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT00873327: Completed Phase 1 study, sponsored by Phillip Brian Smith.
NCT00873327 is a Phase 1 study that has completed, run by Phillip Brian Smith. The registered enrollment target is 32 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00873327, a Phase 1 study, has completed, sponsored by Phillip Brian Smith.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study 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.
Interventions
- DRUG piperacillin-tazobactam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2009-10 |
| Est. Completion | 2010-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00873327
The ClinicalTrials.gov registry entry for NCT00873327 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Phillip Brian Smith, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which piperacillin-tazobactam is the first listed.
NCT00873327 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00873327 about?
NCT00873327 is a clinical study titled "Pharmacokinetics and Safety of Piperacillin-tazobactam in Neonates". 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 w...
What is the current status of trial NCT00873327?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2009-10. Estimated completion is 2010-07.
What interventions are being tested in trial NCT00873327?
The interventions under investigation include: piperacillin-tazobactam (DRUG).
Who is sponsoring clinical trial NCT00873327?
This trial is sponsored by Phillip Brian Smith, which has 6 total clinical trials registered on ClinicalTrials.gov.
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