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NCT04995835 · ClinicalTrials.gov registry record · Phase 1

Cefiderocol PK in Patients on ECMO

A Phase 1 study, sponsored by Joseph L. Kuti, PharmD.

Completed
Registry status
Phase 1
Development phase
5
Enrollment target

NCT04995835: Completed Phase 1 study, sponsored by Joseph L. Kuti, PharmD.

NCT04995835 is a Phase 1 study that has completed, run by Joseph L. Kuti, PharmD. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04995835, a Phase 1 study, has completed, sponsored by Joseph L. Kuti, PharmD.

COMPLETED
Registry status
Phase 1
Development phase
5 participants
Enrollment target

Study Summary

Extracorporeal membrane oxygenation (ECMO) is a form 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 reinfused 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, Cefiderocol, in critically ill patient receiving ECMO.

Primary Outcome

The Clearance in liters/hour of Cefiderocol from the plasma of critically ill patients receiving ECMO.

Interventions

  • DRUG Cefiderocol

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2021-07-16
Est. Completion 2024-09-01
Phase Phase 1
Joseph L. Kuti, PharmD

4 total trials

What the finished NCT04995835 record still lists

NCT04995835 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 1 intervention - of which Cefiderocol is the first listed.

NCT04995835 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04995835 about?

NCT04995835 is a clinical study titled "Cefiderocol PK in Patients on ECMO". Extracorporeal membrane oxygenation (ECMO) is a form 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 reinfused into the patient's circulation. It is well known that critically...

What is the current status of trial NCT04995835?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2021-07-16. Estimated completion is 2024-09-01.

What interventions are being tested in trial NCT04995835?

The interventions under investigation include: Cefiderocol (DRUG).

Who is sponsoring clinical trial NCT04995835?

This trial is sponsored by Joseph L. Kuti, PharmD, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04995835's enrollment target sits among peer trials

5 1989th of 2000 higher than 6 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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Source: ClinicalTrials.gov NCT04995835, the US trial registry maintained by the National Library of Medicine. NCT04995835 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.