Liposomal Amphotericin B and Isavuconazole/Posaconazole in Br-IFD( Breakthrough Invasive Fungal Disease) in Patients With Malignant Hematological Diseases

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

This is a prospective, open label, controlled, single center real-world observational study. Adult (aged ≥ 18 years) patients with hematological malignancies develop breakthrough invasive fungal disease after receiving ≥ 7 days of echinocandin or triazole antifungal prophylaxis receive treatment with liposomal amphotericin B or treatment with Isavuconazole or posaconazole according to the clinical doctor's decision. It is planed to collect 36 patients receiving treatment with liposomal amphotericin B and 36 patients receiving treatment with Isavuconazole or posaconazole, and observe their efficacy and safety.

Eligibility criteria

Qualifiers

Male or female patients aged ≥ 18 years at the beginning of treatment.

The patient or their guardian must be able to understand and sign a written informed consent form (which must be obtained before starting any research procedure)

Blood based diseases, mainly AML( Acute Myeloid Leukemia), ALL(Acute Lymphoblastic Leukemia), MDS(Myelodysplastic Syndromes)

Breakthrough invasive fungal disease occurs after receiving antifungal prophylaxis with triazole drugs for ≥ 7 days

Disqualifiers

Confirmed patients with allergies/rapid onset severe allergic reactions/intolerance to L-AmB or isavuconazole /posaconazole

Serum creatinine level ≥ 2 times the upper limit of normal

The level of transaminase or alkaline phosphatase is ≥ 5 times the normal upper limit, and bilirubin is ≥ 3 times the normal upper limit

Patients who are breastfeeding

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

36 Participants
are grouped into 2 trial groups