Low-dose Liposomal Amphotericin B for Antifungal Prophylaxis in Prolonged Neutropenia Patients
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18-75 lat, obie płci
- •Choroba nowotworowa krwi lub przeszczep szpiku z wysokim ryzykiem grzybicznego zakażenia
- •Liczba neutrofili (rodzaju białych krwinek) ≤0,5×10⁹/L, oczekiwana na ponad 7 dni
- •Dotychczasowe leki przeciwgrzybiczne źle tolerowane lub powodujące efekty uboczne
- •Lekarz zadeklarował niezależnie decyzję o zastosowaniu amfotericyny B w dawce 50 mg dziennie dożylnie
- •Podpisana świadoma zgoda pacjenta lub opiekuna prawnego
✗ Disqualifies
- •Alergia na składniki amfotericyny B lub poważne działania niepożądane w pierwszych 3-5 dniach
- •Wcześniejsze potwierdzone lub podejrzewane grzybiczne zakażenie inwazyjne
- •Obecne objawy zapalenia płuc, gorączka bez wyjaśnionej przyczyny lub znaki grzybicznego zakażenia
- •Niski poziom potasu we krwi (<3,2 mmol/L), którego nie można skorygować przed badaniem
- •Poważne uszkodzenie wątroby (enzymy wątrobowe co najmniej 5 razy powyżej normy)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- August 13, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Haikou Affiliated Hospital of Central South University Xiangya School of Medicine
Hainan, China
Trial contact
Xiaoyang Yang, MD
Guang Cheng, MMed
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/14/2026.
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