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RECRUITING
NCT07725263

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

Sponsor: Haikou Affiliated Hospital of Central South University Xiangya School of Medicine

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

3 Years - 17 Years

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2026-02-01

Completion Date

2027-03-31

Last Updated

2026-07-24

Healthy Volunteers

No

Interventions

DRUG

Liposomal 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