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Compares treatment options for Invasive Mould Infection
Official title Phase 2 EL219 Versus Liposomal Amphotericin B or Voriconazole for Early Antifungal Therapy
ClinicalTrials.gov ID: NCT07215273
What this study is testing
What is EL219?
EL219 is an investigational medicine, given as an once-weekly, being studied as a potential treatment for invasive mould infection.
Also referred to as Formerly SF001, Now EL219 (Turletricin).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants who meet ALL the following will be eligible to participate in the study:
- Willing and able to provide written informed consent.
- 18 years and older, of any gender, race, or ethnicity
- Are at risk for invasive fungal infections (IFIs), by virtue of acquired or inherited immunocompromising condition including but not limited to the...
- Receipt of a blood or marrow transplant (BMT) from an allogeneic donor
You likely can't join if
- Participants must NOT meet any of the following exclusion criteria:
- Participant has received prior antifungal treatment (azole or echinocandin prophylaxis permitted) for \>96 hours prior to randomization.
- Active, microbiologically confirmed systemic bacterial infection with ongoing receipt of antibacterial therapy. Antibacterial prophylaxis and...
- Participants with 1 or more of the following laboratory abnormalities as defined by the National Cancer Institute Common Toxicity Criteria for...
- Alanine aminotransferase (ALT) ≥5 × upper limit of normal (ULN).
- Total serum bilirubin ≥5 × ULN (excluding Gilbert's Syndrome).
See the full eligibility criteria
Who can join
- Participants who meet ALL the following will be eligible to participate in the study:
- Willing and able to provide written informed consent.
- 18 years and older, of any gender, race, or ethnicity
- Are at risk for invasive fungal infections (IFIs), by virtue of acquired or inherited immunocompromising condition including but not limited to the following:
- Receipt of a blood or marrow transplant (BMT) from an allogeneic donor
- Active hematologic malignancy.
- Recent neutropenia with absolute neutrophil count \ 10 days
- Receipt of corticosteroids at mean minimum doses of 0.3 mg/kg/day prednisone equivalent for \>3 weeks.
- Receipt of other recognized T-cell immunosuppressants, such as cyclosporin, tumor necrosis factor alpha (TNF-α) blockers, or specific monoclonal antibodies during the last 3 months.
- Inherited severe immunodeficiency
- Has suspected or confirmed mould infection (IMI) supported by one or both of the following:
- Results of an assay having regulatory clearance in Europe or the United States (Conformité Européene [CE] mark or United States Food and Drug Administration [US FDA] 510k clearance), demonstrating positivity at...
- Abnormal findings on chest computed tomography (CT) scan without alternative microbiologic diagnosis Note: If CT of the chest is used to establish eligibility it must be performed within 7 days prior to randomization.
- Must have IV access in place or to be placed prior to beginning IV study therapy.
- Must be willing to adhere to dosing, study visit schedule, and mandatory diagnostic procedures.
- Female participants must meet 1 of the following criteria:
- A woman of childbearing potential (WOCBP) must agree to use a highly effective, preferably user-independent method of contraception (failure rate of \<1% per year when used consistently and correctly) for at least 30...
- A female of non-childbearing potential must be surgically sterile (i.e., have undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation/occlusion without reversal surgery) or in a menopausal state (at...
- A WOCBP must have a negative pregnancy test (highly sensitive serum β-human chorionic gonadotropin or a urine test) during both the current hospitalization AND on Day -1 before study drug administration.
- Females must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of at least 2 months after study drug administration.
- Male participants must be vasectomized or agree to abstain from intercourse or if engaging in sexual activity that has risk of pregnancy, must agree to use a double barrier method (e.g. condom and spermicide) and agree...
What rules you out
- Participants must NOT meet any of the following exclusion criteria:
- Participant has received prior antifungal treatment (azole or echinocandin prophylaxis permitted) for \>96 hours prior to randomization.
- Active, microbiologically confirmed systemic bacterial infection with ongoing receipt of antibacterial therapy. Antibacterial prophylaxis and secondary therapy is allowed, providing that follow-up cultures have been...
- Participants with 1 or more of the following laboratory abnormalities as defined by the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v5.0:
- Alanine aminotransferase (ALT) ≥5 × upper limit of normal (ULN).
- Total serum bilirubin ≥5 × ULN (excluding Gilbert's Syndrome).
- Serum creatinine ≥2 mg/dL or creatinine clearance (CrCL) ≤30 mL/minute.
- Known cirrhosis of the liver, diagnosed according to country or Medical Society-specific guidelines and documented in the medical records prior to screening.
- Known New York Heart Association (NYHA) Class III or Class IV heart failure.
- Diagnosed reduced lung function with either diffusion capacity (corrected for hemoglobin) or forced expiratory volume in 1 second (FEV1) ≤65% of predicted value, or oxygen (O2) saturation ≤82% on room air.
- Receiving either hemodialysis or peritoneal dialysis.
- Personal or family history of long QT interval on ECG (QT) syndrome or a prolonged QT interval corrected for heart rate by Fridericia's formula (QTcF; \>470 msec in males and \>490 msec in females).
- If the Investigator chooses voriconazole as Comparator therapy, current or projected use of the following medications or drug classes known to interact with voriconazole: terfenadine, astemizole, cisapride, pimozide...
- If the Investigator chooses voriconazole as Comparator therapy, history of hereditary problems with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- Known hypersensitivity to EL219 Powder for Injection, polyenes, or known hypersensitivity to voriconazole if the Investigator chooses voriconazole as Comparator therapy.
- History of severe allergic response to mRNA-based severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine and/or polyethylene glycol (PEG)-containing products.
- Previous participation in any study using an investigational drug within 5 half-lives of the drug, or intention to use investigational drug before completion of the Day 56 Safety Follow-Up. Concurrent participation in...
- Prior recipient of orthotopic lung transplant.
- Imminent transition to hospice or withdrawn care such as with refractory malignancy or multiorgan failure.
- Female participants who are pregnant or lactating or planning to become pregnant within 2 months following study drug administration.
- The Principal Investigator (PI) determines the participant should not participate in the study.
- Considered unlikely to follow up for required days due to logistic concerns (i.e., home location relative to study site).
- Persons committed to an institution by virtue of an order issued either by the judicial or the administrative authorities or are in a dependent relationship with the Sponsor or the Investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Sacramento, California, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- St Louis, Missouri, United States
- Houston, Texas, United States
- Bruges, Belgium
- Brussels, Belgium
- Leuven, Belgium
- Hamilton, Ontario, Canada
- Argenteuil, France
- Créteil, France
- Milan, Italy
- Roma, Italy
- Barcelona, Spain
- Salamanca, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Sacramento, California, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States; St Louis, Missouri, United States; Houston, Texas, United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.