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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

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.

Eligibility criteria

Qualifiers

The children and adolescent patients with hematological malignancy received echinocandin/triazole for antifungal prophylaxis and diagnosed with br-IFD.

Age: from 1 month to 18 years old.

Diagnosed patients with hematological malignancy.

Received echinocandin/triazole for antifungal prophylaxis at least 7 days.

Disqualifiers

(a) Received AmB formulation for prophylaxis or treatment within the past 30 days.

Trial design

Treatments tested in this trial

  • Patients received the Drug: liposomal amphotericin B(AmBisome) for treatment

Treatment groups

38 Participants
are divided into 1 treatment group

Sponsors and collaborators