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Anti-fungal

Rezafungin for Sepsis

Phase 1
Waitlist Available
Led By Joseph L. Kuti, PharmD
Research Sponsored by Hartford Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 168 hours
Awards & highlights

Study Summary

This trial will look at how a new medication, Rezafungin, behaves in critically ill patients who are receiving ECMO life support. ECMO involves pumping the patient's blood outside the body

Who is the study for?
This trial is for critically ill patients with sepsis who are receiving ECMO, a life-support treatment that helps the heart and lungs function. The study aims to include those who need to understand how their treatment affects drug levels in the body.Check my eligibility
What is being tested?
The focus of this trial is on Rezafungin, a new medication intended to fight fungal infections. Researchers want to see how being on ECMO changes the way this drug works in the body by studying its pharmacokinetics or how it moves through and is processed by patients.See study design
What are the potential side effects?
Since Rezafungin is an antifungal medication, potential side effects may include allergic reactions, liver enzyme abnormalities, gastrointestinal symptoms like nausea or diarrhea, headache, infusion-related reactions, and blood count changes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~168 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 168 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rezafungin Clearance
Secondary outcome measures
Rezafungin Area Under the Curve (AUC)

Side effects data

From 2021 Phase 3 trial • 199 Patients • NCT03667690
9%
Anaemia
9%
Hypokalaemia
8%
Septic shock
7%
Diarrhoea
6%
Hypotension
6%
Urinary tract infection
5%
Acute kidney injury
5%
Pyrexia
4%
Respiratory failure
4%
Sepsis
4%
Abdominal pain
4%
Hypophosphataemia
3%
Pneumonia
3%
Klebsiella sepsis
3%
Abdominal abscess
3%
Hypomagnesaemia
3%
Constipation
2%
Hyperkalaemia
2%
Intra-abdominal haemorrhage
2%
Bacterial sepsis
2%
Multiple organ dysfunction syndrome
2%
Pneumonia aspiration
2%
COVID-19 pneumonia
2%
Vomiting
2%
Nausea
1%
COVID-19
1%
Proctitis
1%
Acinetobacter sepsis
1%
Atrial fibrillation
1%
Pneumonia klebsiella
1%
Large intestine perforation
1%
Asthenia
1%
Neoplasm malignant
1%
Acute respiratory distress syndrome
1%
Pleural effusion
1%
Pneumonia lipoid
1%
Bacteraemia
1%
Splenic haemorrhage
1%
Supraventricular tachycardia
1%
Diverticulum
1%
Haematochezia
1%
Intestinal obstruction
1%
Liver injury
1%
Anaphylactic shock
1%
Enterococcal sepsis
1%
Drain site complication
1%
Weight decreased
1%
Dehydration
1%
Hyperglycaemic hyperosmolar nonketotic syndrome
1%
Haematoma muscle
1%
Hypertensive encephalopathy
1%
Aspiration
1%
Metastases to central nervous system
1%
Ventricular tachycardia
1%
Hernia
1%
Cardio-respiratory arrest
1%
Colitis
1%
Hypertransaminasaemia
1%
Meningitis
1%
Vascular device infection
1%
Encephalopathy
1%
Intestinal ischaemia
1%
Abdominal infection
1%
Hepatic infarction
1%
Pseudomonal sepsis
1%
Pyelonephritis
1%
Septic pulmonary embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 2: Caspofungin
Group 1: Rezafungin for Injection

Trial Design

1Treatment groups
Experimental Treatment
Group I: RezafunginExperimental Treatment1 Intervention
Participants will receive one dose of rezafungin as per current prescribing information.

Find a Location

Who is running the clinical trial?

Hartford HospitalLead Sponsor
133 Previous Clinical Trials
18,924 Total Patients Enrolled
1 Trials studying Sepsis
9 Patients Enrolled for Sepsis
Melinta Therapeutics, LLCIndustry Sponsor
2 Previous Clinical Trials
252 Total Patients Enrolled
Joseph L. Kuti, PharmDPrincipal InvestigatorHartford Hospital
1 Previous Clinical Trials
16 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are eligible patients able to enroll in this ongoing trial at the present time?

"According to clinicaltrials.gov, this particular study is presently not accepting new participants. Initially uploaded on the 4th of January in 2024 and last revised on the 19th of March in that same year, it does not currently seek enrollees. Nevertheless, there are a total of 181 alternative trials actively seeking participants at this moment."

Answered by AI

Has Rezafungin been granted approval by the FDA?

"In this Phase 1 trial, Rezafungin's safety rating is low at 1 due to the limited data available supporting its safety and effectiveness."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Rezafungin PK in Patients on ECMO
Joseph L. Kuti, PharmD 2024. "Rezafungin PK in Patients on ECMO". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06329518.
All > Ecmo > Sepsis
~5 spots leftby Apr 2025
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