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Clinical Trials in the EU / 2025-521505-40-00
Authorised, not yet recruiting Phase II

CombiMucor - Efficacy of combination therapy with isavuconazole and intermittent high doses liposomal amphotericin B for the treatment of mucormycosis

2025-521505-40-00 · tracked via the Priya Life Science EU tracker
Sponsor
Assistance Publique Hopitaux De Paris
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Bacterial Infections and Mycoses
Decision date
09/10/2026
Enrollment target
52
Sites
France

Condition studied

Adults with mucormycosis

Investigational medicinal product(s)

CRESEMBA 100 mg hard capsulesCRESEMBA 200 mg powder for concentrate for solution for infusionAMBISOME liposomal 50 mgpoudre pour dispersion pour perfusion

Every trial of Amphotericin B across our registers →

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

The primary end-point is the success defined as a favorable global response (complete or partial response) at week 4 according to adapted EMSGERC/ECMM 2026 response criteria.

Endpoint detail

occurrence of severe and non-severe adverse events from the inclusion to W4, favorable global response (complete or partial response) at W6 and M3 according to adapted MSGERC/ECMM 2026 response criteria, favorable global response (complete or partial response) at W4, W6 and M3 according to MSGERC/ECMM 2026 response criteria, survival at W4, W6, M3 and M6, radiological response on CT scan at D14 and negative qPCR at D14, result of the qPCR at D7 and D14, slope of DNA load between D1-D7 and D1-D14, through level of ISZ at D7, D14 and W4, immunological Mucorales elispot at D1 and W4, time to qPCR negativation

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-521505-40-00 on CTIS ↗ ← All trials in the EU