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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). 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.
Primary Outcome
To study how Piperacillin is metabolized in the body by measuring the drug concentration in plasma samples collected at different time points during the study
Interventions
- DRUG piperacillin-tazobactam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2009-10 |
| Est. Completion | 2010-07 |
| Phase | Phase 1 |
What the finished NCT00873327 record still lists
NCT00873327 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 1 intervention - of which piperacillin-tazobactam is the first listed.
NCT00873327 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00873327's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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