Clinical Trial

A Real-world Prospective Observational Study on the Efficacy and Safety of L-AmB(Liposomal Amphotericin B) for br- IFD(Breakthrough Invasive Fungal Disease) in Children and Adolescent Patients With Hematological Malignancies Receiving Triazoles or Echinocandins Prophylaxis

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Summary
The goal of this observational study is to evaluate the efficacy the favorable response rate and safety of L-AmB(liposomal amphotericin B) for the treatment of br-IFD(breakthrough invasive fungal disease) in Chinese children and adolescent patients with hematological malignancies receiving triazoles/echinocandins antifungal prophylaxis. The main question it aims to answer is: 1. Whether the L-AmB have the same efficacy in the treatment of br-IFD in Chinese children and adolescent with hematological malignancies who are receiving triazoles or echinocandins antifungal prophylaxis as in adults(compared with historical data) 2. Whether L-AmB may have better renal safety in Chinese children and adolescent than in adults (compared with historical data). Chinese children and adolescent with hematological malignancies will taking L-AmB as part of their regular medical care for br-IFD. The efficacy and safety data will be recorded.
Trial Details
NCT Number NCT07357038
Lead Sponsor Institute of Hematology & Blood Diseases Hospital, China
Collaborators: Gilead Sciences
Conditions Fungal Disease
Enrollment 38 participants
Start Date 2025-09-30
Primary Completion 2027-02-28 (estimated)
Study Completion 2027-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-21