Low-dose Liposomal Amphotericin B for Antifungal Prophylaxis in Prolonged Neutropenia Patients

Sponsor
Haikou Affiliated Hospital of Central South University Xiangya School of Medicine
Study ID
NCT07763054
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Liposomal Amphotericin B — DRUG
    Liposomal amphotericin B at 50 mg/day, administered intravenously once daily, for antifungal prophylaxis in patients with prolonged neutropenia. Liposomal amphotericin B is a broad-spectrum polyene antifungal agent with activity against most pathogenic fungi, including Candida, Aspergillus, and Mucorales species. The liposomal formulation reduces nephrotoxicity compared to conventional amphotericin B deoxycholate while maintaining equivalent antifungal activity.

Study Details

This is a single-center, single-arm, observational clinical study evaluating the efficacy and safety of low-dose liposomal amphotericin B (50 mg/day, intravenous, once daily) for the prevention of invasive fungal infections in adult patients (aged 18-75 years) with hematological malignancies who develop prolonged neutropenia (absolute neutrophil count ≤0.5×10\^9/L, expected to last \>7 days) and are at high risk for invasive fungal disease. Participants are those who, per the treating physician's routine clinical decision, have been initiated on liposomal amphotericin B prophylaxis at 50 mg/day due to intolerance or toxicity to other antifungal agents. The primary outcome is the incidence of proven or probable invasive fungal disease. Secondary outcomes include incidence of pneumonia, persistent unexplained fever \>4 days, use of additional systemic antifungal therapy, and adverse events. A total of 30 participants will be enrolled. Data will be collected at baseline, during treatment, and within 7 days after treatment completion.

Key Dates

First listed
Aug 13, 2026
Start date
Aug 1, 2025
Status verified
Aug 2026
Primary completion
Aug 31, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Liposomal Amphotericin B Prophylaxis Group
    Adult patients with hematological malignancies who meet NCCN 2025 V1 high-risk criteria for invasive fungal disease, with expected neutropenia \>7 days (absolute neutrophil count ≤0.5×10\^9/L). Participants receive liposomal amphotericin B at 50 mg/day, intravenous, once daily, as antifungal prophylaxis initiated by the treating physician in routine clinical practice due to intolerance or toxicity to other antifungal agents.

Primary Outcome Measure

Incidence of Proven or Probable Invasive Fungal Disease [ Time Frame: From baseline to 7 days after the end of antifungal prophylaxis treatment ]

Central Contacts

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