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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 is a Phase 1 study that has completed, run by Joseph L. Kuti, PharmD. The registered enrollment target is 8 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04493151
The ClinicalTrials.gov registry entry for NCT04493151 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Joseph L. Kuti, PharmD, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Imipenem, Cilastatin and Relebactam is the first listed.
NCT04493151 reports 0 study locations.
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.
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