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NCT01587495 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics and Safety of Ertapenem in the Postpartum Period
A Phase 1 study, sponsored by Daniel Benjamin.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT01587495: Clinical Trial Phase 1 study, sponsored by Daniel Benjamin.
NCT01587495 is a Phase 1 study that was terminated before completion, run by Daniel Benjamin. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01587495, a Phase 1 study, was terminated before completion, sponsored by Daniel Benjamin.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
The investigators are doing this study to learn more about the dosing and safety of ertapenem in women with suspected serious infections less than 42 days from the delivery of their infant.
Primary Outcome
The fraction of unbound drug will be calculated using total and unbound drug concentrations. The appropriate non-compartmental pharmacokinetic parameters will be computed, including AUC24, AUCss, Cmax, CL, Vss, t1/2. PK parameters will be summarized by study cohort and compared using standard statistical methodology.
Interventions
- DRUG Ertapenem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2012-03 |
| Est. Completion | 2014-01 |
| Phase | Phase 1 |
Why NCT01587495 stopped before completion
NCT01587495 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Ertapenem is the first listed.
NCT01587495 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01587495 about?
NCT01587495 is a clinical study titled "Pharmacokinetics and Safety of Ertapenem in the Postpartum Period". The investigators are doing this study to learn more about the dosing and safety of ertapenem in women with suspected serious infections less than 42 days from the delivery of their infant.
What is the current status of trial NCT01587495?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2012-03. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01587495?
The interventions under investigation include: Ertapenem (DRUG).
Who is sponsoring clinical trial NCT01587495?
This trial is sponsored by Daniel Benjamin, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01587495's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 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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