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Anti-fungal

Rezafungin for Sepsis

Phase 1
Recruiting
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

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.
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.
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rezafungin Clearance
Secondary study objectives
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%
Intra-abdominal haemorrhage
2%
Bacterial sepsis
2%
Hyperkalaemia
2%
Multiple organ dysfunction syndrome
2%
Pneumonia aspiration
2%
COVID-19 pneumonia
2%
Vomiting
2%
Nausea
1%
Ventricular tachycardia
1%
Acinetobacter sepsis
1%
COVID-19
1%
Pneumonia klebsiella
1%
Atrial fibrillation
1%
Large intestine perforation
1%
Proctitis
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%
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
138 Previous Clinical Trials
19,389 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
~5 spots leftby Apr 2025
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