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Low-dose Liposomal Amphotericin B for Antifungal Prophylaxis in Prolonged Neutropenia Patients
Sponsor: Haikou Affiliated Hospital of Central South University Xiangya School of Medicine
Summary
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.
Official title: Evaluation of Low-Dose Liposomal Amphotericin B for Prophylaxis of Invasive Fungal Infections in Patients With Prolonged Neutropenia: A Clinical Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
30
Start Date
2025-08-01
Completion Date
2026-11-30
Last Updated
2026-08-13
Healthy Volunteers
No
Conditions
Interventions
Liposomal Amphotericin B
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.
Locations (1)
Haikou Affiliated Hospital of Central South University Xiangya School of Medicine
Hainan, Hainan, China