Rezafungin Pharmacokinetics in Patients on ECMO | NCT06329518

Studies
Rezafungin Pharmacokinetics in Patients on ECMO

NCT06329518

Sponsor

Hartford Hospital

Status

Withdrawn

Last Update Posted

Dec 17, 2024Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Sepsis

Interventions

Rezafungin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI departure

Expanded Access Info

Start Date

Jul 1, 2024Actual

Primary Completion Date

Dec 11, 2024Actual

Completion Date

Dec 11, 2024Actual

First Submitted Date

Mar 19, 2024

First Submission Date that Met QC Criteria

Mar 19, 2024

First Posted Date

Mar 26, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2024

Last Update Posted Date

Dec 17, 2024Actual

Name	Class
Melinta Therapeutics, LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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 echinocandin, Rezafungin, in critically ill patients receiving ECMO

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rezafungin	Experimental	Participants will receive one dose of rezafungin as per current prescribing information.	Drug: Rezafungin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rezafungin	Drug	After receipt of Rezafungin, blood samples will be collected at various time points to determine the pharmacokinetics of Rezafungin.	Rezafungin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rezafungin Clearance	The Clearance in liters/hour of Rezafungin from the plasma of critically ill patients receiving ECMO	168 hours

Secondary Outcomes

Measure	Description	Time Frame
Rezafungin Area Under the Curve (AUC)	The AUC in milligram*hour/liter of Rezafungin calculated from concentrations collected between zero and 168 hours at steady-state.	168 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes