RecruitingNCT07725263

Low-Dose Liposomal Amphotericin B for Invasive Fungal Infection Prophylaxis in Neutropenic Children

Evaluation of Efficacy and Safety of Low-Dose Liposomal Amphotericin B in Prophylaxis of Invasive Fungal Infections Among Children With Prolonged Neutropenia: A Clinical Study


Sponsor

Haikou Affiliated Hospital of Central South University Xiangya School of Medicine

Enrollment

30 participants

Start Date

Feb 1, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

This is a single-center, single-arm, observational clinical study evaluating the efficacy and safety of low-dose liposomal amphotericin B (1 mg/kg/day, intravenous, once daily) for the prevention of invasive fungal infections in children aged 3-17 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 1 mg/kg/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.


Eligibility

Min Age: 3 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Liposomal Amphotericin B (LAmB) for people with graft vs host disease, hematopoietic stem cell transplantation, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged {} to 3 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLiposomal Amphotericin B (LAmB)

Liposomal amphotericin B at 1 mg/kg/day, administered intravenously once daily, for antifungal prophylaxis in children 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

Haikou, Hainan, China

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NCT07725263


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