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NCT04493151 · ClinicalTrials.gov registry record · Phase 1
Imipenem/Cilastatin/Relebactam PK in ECMO
A Phase 1 study, sponsored by Joseph L. Kuti, PharmD.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT04493151: Completed Phase 1 study, sponsored by Joseph L. Kuti, PharmD.
NCT04493151 is a Phase 1 study that has completed, run by Joseph L. Kuti, PharmD. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04493151, a Phase 1 study, has completed, sponsored by Joseph L. Kuti, PharmD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
Extracorporeal membrane oxygenation (ECMO) is a from of cardiopulmonary life-support for critically ill patients where blood is extracted from the vascular system and circulated by a mechanical pump while it is oxygenated and re-infused into the patient's circulation. It is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. There is a need to understand how ECMO circuits affect the pharmacokinetics and disposition of drugs. This study is designed to assess the pharmacokinetics of the new broad-spectrum antibiotic, imipenem-cilastatin-relebactam, in critically ill patients receiving ECMO.
Primary Outcome
The clearance in liters/hour of imipenem from the plasma of critically ill patients receiving ECMO.
Interventions
- DRUG Imipenem, Cilastatin and Relebactam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2021-01-01 |
| Est. Completion | 2023-06-30 |
| Phase | Phase 1 |
What the finished NCT04493151 record still lists
NCT04493151 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Imipenem, Cilastatin and Relebactam is the first listed.
NCT04493151 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04493151 about?
NCT04493151 is a clinical study titled "Imipenem/Cilastatin/Relebactam PK in ECMO". Extracorporeal membrane oxygenation (ECMO) is a from of cardiopulmonary life-support for critically ill patients where blood is extracted from the vascular system and circulated by a mechanical pump while it is oxygenated and re-infused into the patient's circulation. It is well known that criticall...
What is the current status of trial NCT04493151?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2021-01-01. Estimated completion is 2023-06-30.
What interventions are being tested in trial NCT04493151?
The interventions under investigation include: Imipenem, Cilastatin and Relebactam (DRUG).
Who is sponsoring clinical trial NCT04493151?
This trial is sponsored by Joseph L. Kuti, PharmD, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04493151's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 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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