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Rezafungin Pharmacokinetics in Patients on ECMO

NCT ID: NCT06329518

Last Updated: 2024-12-17

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

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2024-12-11

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 echinocandin, Rezafungin, in critically ill patients receiving ECMO

Detailed Description

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This is a prospective, open-label, Phase 1b, pharmacokinetic study of Rezafungin 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 echinocandins

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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Rezafungin

Participants will receive one dose of rezafungin as per current prescribing information.

Group Type EXPERIMENTAL

Rezafungin

Intervention Type DRUG

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

Interventions

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Rezafungin

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

Intervention Type DRUG

Other Intervention Names

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rezafungin acetate

Eligibility Criteria

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Inclusion Criteria

* Age 18 years or older
* Receiving venovenous or venoarterial ECMO support.

Exclusion Criteria

* Females who are pregnant or breast-feeding
* History of any moderate or severe hypersensitivity or allergic reaction to any echinocandin antifungal
* Receiving rezafungin to treat documented or suspected infection within 14 days of screening, or expected to receive rezafungin during the study intervention phase
* Receiving or likely to require intermittent 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
* Patients expected to have ECMO discontinued within the next 24 hours
* 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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Melinta Therapeutics, LLC

INDUSTRY

Sponsor Role collaborator

Hartford Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joseph L. Kuti, PharmD

Director, Center for Anti-Infective Research and Development

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph L. Kuti, PharmD

Role: PRINCIPAL_INVESTIGATOR

Hartford Hospital

Countries

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United States

Other Identifiers

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HHC-2024-0064

Identifier Type: -

Identifier Source: org_study_id