Actively Recruiting
Phase 2 EL219 Versus Liposomal Amphotericin B or Voriconazole for Early Antifungal Therapy
Led by Elion Therapeutics, Inc. · Updated on 2026-05-06
60
Participants Needed
6
Research Sites
41 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine if EL219 is safe and effective compared to liposomal amphotericin B (LAmB) or voricanozole for early treatment of invasive mould infections
CONDITIONS
Official Title
Phase 2 EL219 Versus Liposomal Amphotericin B or Voriconazole for Early Antifungal Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent
- 18 years and older, any gender, race, or ethnicity
- At risk for invasive fungal infections due to conditions such as allogeneic blood or marrow transplant, active hematologic malignancy, recent prolonged neutropenia, corticosteroid use, other T-cell immunosuppressants, or inherited severe immunodeficiency
- Suspected or confirmed invasive mould infection supported by approved diagnostic tests or abnormal chest CT scan within 7 days prior to randomization
- Have or able to have intravenous access before starting study therapy
- Willing to follow dosing, visit schedules, and required diagnostic procedures
- Female participants must either use effective contraception if of childbearing potential or be surgically sterile, menopausal, or confirmed menopausal by hormone levels
- Negative pregnancy test during current hospitalization and the day before study drug administration if female and of childbearing potential
- Agree not to donate eggs during the study and for two months after drug administration if female
- Male participants must be vasectomized or agree to use double barrier contraception and not donate sperm during the study and for 120 days after drug administration
You will not qualify if you...
- Prior antifungal treatment for more than 96 hours before randomization (except azole or echinocandin prophylaxis)
- Active systemic bacterial infection with ongoing antibacterial therapy (prophylaxis or secondary therapy allowed if cultures negative for over 2 days)
- Significant laboratory abnormalities including very high liver enzymes, bilirubin, or poor kidney function
- Known liver cirrhosis
- Severe heart failure (NYHA Class III or IV)
- Reduced lung function or low oxygen saturation on room air
- Receiving hemodialysis or peritoneal dialysis
- Personal or family history of long QT syndrome or prolonged QT interval
- If assigned voriconazole, use of certain medications that interact with it or history of certain hereditary digestive disorders
- Known allergies to study drugs or related compounds
- History of severe allergic reaction to mRNA COVID-19 vaccines or polyethylene glycol products
- Recent participation in another investigational drug study within five half-lives or intention to use investigational drugs before safety follow-up completion
- Prior lung transplant
- Imminent transition to hospice or withdrawn care
- Pregnant, lactating, or planning pregnancy within 2 months after study drug administration
- Investigator judgment against participation
- Unlikely to complete follow-up visits due to logistical reasons
- Institutionalized persons or those in dependent relationships with study sponsors or investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
U. of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
UC Davis Medical Center
Sacramento, California, United States, 95817
Actively Recruiting
3
U. of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
4
Washington U.
St Louis, Missouri, United States, 63110
Actively Recruiting
5
U. of Texas, MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
6
Juravinski Hospital
Hamilton, Ontario, Canada, L8V 1C3
Actively Recruiting
Research Team
L
Laura A. Navalta
CONTACT
G
Gordana Schnider, MHA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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