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Cefiderocol PK in Patients on ECMO

NCT ID: NCT04995835

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-16

Study Completion Date

2024-09-01

Brief Summary

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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.

Detailed Description

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This is a prospective, open-label, Phase 1b, pharmacokinetic study of Cefiderocol in 8 critically ill patients receiving ECMO support at Hartford Hospital. Informed consent will be collected from all study participants, legal authorized representative, or their next of kin in order to participate. This is not a treatment study; all participants will receive other antibiotics as necessary to treat any current infection.

Conditions

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Sepsis

Keywords

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pharmacokinetics Cephalosporins

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cefiderocol

Participants will receive four to six doses of Cefiderocol as per current prescribing information based on calculated creatinine clearance.

Group Type EXPERIMENTAL

Cefiderocol

Intervention Type DRUG

After receipt of Cefiderocol, blood samples will be collected at various time points to determine the pharmacokinetics of Cefiderocol

Interventions

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Cefiderocol

After receipt of Cefiderocol, blood samples will be collected at various time points to determine the pharmacokinetics of Cefiderocol

Intervention Type DRUG

Other Intervention Names

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Fetroja

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* On support with veno-venous- or veno-arterial-ECMO

Exclusion Criteria

* Females who are pregnant or breast-feeding
* History of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibiotic (a history of mild rash to a cephalosporin followed by uneventful re-exposure is not a contraindication)
* Receiving Cefiderocol to treat documented or suspected infection within 72 hours of screening, or expected to receive Cefiderocol during the study intervention phase
* Severe renal dysfunction defined as a CrCL \< 15 mL/min (as calculated by the Cockcroft Gault equation using actual body weight) or requirement for continuous renal replacement therapy or hemodialysis
* A hemoglobin less than 7.2 gm/dl at baseline
* Acute liver injury, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 times the upper limit of normal, or AST or ALT \> 3 times the upper limit of normal with an associated total bilirubin \> 2 times upper limit of normal
* Any rapidly progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator)
* Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of study data.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shionogi Inc.

INDUSTRY

Sponsor Role collaborator

Joseph L. Kuti, PharmD

OTHER

Sponsor Role lead

Responsible Party

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Joseph L. Kuti, PharmD

Director, Center for Anti-Infective Research and Development

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Joseph L Kuti, PharmD

Role: PRINCIPAL_INVESTIGATOR

Hartford Hospital

Locations

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Hartford Hospital

Hartford, Connecticut, United States

Site Status

Columbia University/New York Presbyterian Hospital

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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HHC-2021-0086

Identifier Type: -

Identifier Source: org_study_id