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Phase 2 EL219 versus Liposomal Amphotericin B for Early Antifungal Therapy
EU CTIS ID: 2025-522835-32-00
What this study is testing
Evaluate the efficacy and safety of EL219 compared to liposomal amphotericin B (LAmB) followed by voriconazole for early antifungal therapy (EAT) of suspected invasive mould infections (IMIs).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1_Males or females 18 years and older
- 2_Présenter un risque d’infections fongiques invasives (IFI), au motif d’au moins 1 des éléments suivants : -Avoir reçu une greffe de moelle osseuse d’un donneur allogénique, avec du sang, de la moelle osseuse ou du sang de cordon comme source de cellules souches. -Recevoir actuellement ou avoir reçu récemment (dans un délai de 1 mois) des traitement(s) cytotoxique(s), biologique(s) ou immunomodulateur(s) pour traiter une tumeur maligne hématologique. -Avoir reçu des corticoïdes à des doses minimales moyennes de 0,3 mg/kg/jour d’équivalent prednisone pendant plus de 3 semaines. -Avoir reçu d’autres immunosuppresseurs reconnus agissant sur les lymphocytes T, tels que la cyclosporine, des inhibiteurs du facteur de nécrose tumorale alpha (TNF-α) ou des anticorps monoclonaux spécifiques au cours des 3 derniers mois.
- 3_Has suspected invasive mould infection (IMI) as defined in the protocol
- 4_Must be willing to adhere to dosing, study visit schedule, and mandatory procedures as described in the protocol
You likely can't join if
- 1_Diagnosis of proven or probable IMI within 1 month prior to randomization (including meeting the criteria for proven or probable IMI during the screening period), or relapsed/recurrent IMI which has not responded to other antifungal therapies
- 2_Prior antifungal treatment (azole prophylaxis permitted) for >96 hours prior to randomization or would require use of non-study antifungals during the period of the study
- 3_Systemic bacterial infection diagnosed within the 14 days prior to randomization
- 4_Presence of 1 or more of the following laboratory abnormalities: -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
- 5_Presence of 1 or more of the following concomitant diseases: -Known cirrhosis of the liver - Diagnosed symptomatic heart failure -Diagnosed reduced lung function
- 6_Receiving either hemodialysis or peritoneal dialysis
See the full eligibility criteria
- 1_Males or females 18 years and older
- 2_Présenter un risque d’infections fongiques invasives (IFI), au motif d’au moins 1 des éléments suivants : -Avoir reçu une greffe de moelle osseuse d’un donneur allogénique, avec du sang, de la moelle osseuse ou du sang de cordon comme source de cellules souches. -Recevoir actuellement ou avoir reçu récemment (dans un délai de 1 mois) des traitement(s) cytotoxique(s), biologique(s) ou immunomodulateur(s) pour traiter une tumeur maligne hématologique. -Avoir reçu des corticoïdes à des doses minimales moyennes de 0,3 mg/kg/jour d’équivalent prednisone pendant plus de 3 semaines. -Avoir reçu d’autres immunosuppresseurs reconnus agissant sur les lymphocytes T, tels que la cyclosporine, des inhibiteurs du facteur de nécrose tumorale alpha (TNF-α) ou des anticorps monoclonaux spécifiques au cours des 3 derniers mois.
- 3_Has suspected invasive mould infection (IMI) as defined in the protocol
- 4_Must be willing to adhere to dosing, study visit schedule, and mandatory procedures as described in the protocol
- 1_Diagnosis of proven or probable IMI within 1 month prior to randomization (including meeting the criteria for proven or probable IMI during the screening period), or relapsed/recurrent IMI which has not responded to other antifungal therapies
- 2_Prior antifungal treatment (azole prophylaxis permitted) for >96 hours prior to randomization or would require use of non-study antifungals during the period of the study
- 3_Systemic bacterial infection diagnosed within the 14 days prior to randomization
- 4_Presence of 1 or more of the following laboratory abnormalities: -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
- 5_Presence of 1 or more of the following concomitant diseases: -Known cirrhosis of the liver - Diagnosed symptomatic heart failure -Diagnosed reduced lung function
- 6_Receiving either hemodialysis or peritoneal dialysis
- 7_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 >480 msec in females)
- 8_Prior recipient of orthotopic lung transplant
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Canada
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Canada. 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 EU CTIS; the study team decides eligibility.