Can a safer dose of an old drug shield vulnerable children from deadly fungal infections?
NCT ID NCT07725263
First seen Jul 24, 2026 · Last updated Jul 24, 2026
Summary
This trial tests whether a low dose of the antifungal drug liposomal amphotericin B can prevent invasive fungal infections in children aged 3 to 17 who have prolonged neutropenia (very low white blood cell counts) after cancer treatment or stem cell transplant. The drug is given intravenously once daily to children already at high risk. Researchers will track how many develop a proven or probable fungal infection, as well as side effects, to see if this approach is both effective and safer than standard doses.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a low-dose form of the antifungal drug liposomal amphotericin B, given intravenously once daily
- What this could lead to
- If it works, this could offer a safer way to prevent life-threatening fungal infections in children with weakened immune systems.
- What could go wrong
- This is a small, single-center study with only 30 participants, so results may not apply broadly. The drug can still cause kidney problems or other side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Children aged 3-17 years with thalassemia or other hematological conditions who undergo allogeneic hematopoietic stem cell transplantation or other intensive therapies associated with prolonged neutropenia (\>7 days), meet NCCN 2025 V1 high-risk criteria for invasive fungal disease, and have been initiated on liposomal amphotericin B prophylaxis at 1 mg/kg/day by the treating physician in routine clinical practice due to intolerance or toxicity to other antifungal agents.
- Ages
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3 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 3 to 17 years (inclusive), both sexes. * Meets NCCN 2025 V1 guideline criteria for high-risk invasive fungal disease, including allogeneic hematopoietic stem cell transplantation, autologous hematopoietic cell transplantation with mucosal damage, acute leukemia, grade 3/4 graft-versus-host disease, myelodysplastic syndrome, lymphoma(a), multiple myeloma(a), chronic lymphocytic leukemia(a), treatment with purine analogues (fludarabine, clofarabine, nelarabine), chimeric antigen receptor (CAR) T-cell therapy, alemtuzumab therapy, with expected neutropenia \>7 days(b) and accompanied by agranulocytosis. Note (a): For these heterogeneous diseases, myeloablative therapy must be met; if neutropenia \>7 days is not met, the patient should be excluded. Note (b): Agranulocytosis is defined as absolute neutrophil count ≤0.5×10\^9/L, or absolute neutrophil count ≤1×10\^9/L with expected decline to ≤0.5×10\^9/L within 48 hours. * Assessed by the study physician as having high-risk for invasive fungal infection, intolerant or unable to use other antifungal agents due to toxicity or other reasons, and the treating physician has independently decided in routine clinical practice to initiate liposomal amphotericin B for antifungal prophylaxis for 3-5 days, with the selected dosage regimen of 1 mg/kg/day, intravenous, once daily. * Patient or legally authorized representative has voluntarily signed the informed consent form. Exclusion Criteria: * Allergy to any component of liposomal amphotericin B, or development of serious adverse events during the initial 3-5 days of prophylactic use. * Prior history of proven or probable invasive fungal disease (IFD). * Presence of pneumonia, unexplained fever, or clinical/imaging evidence suggestive of or diagnosed as fungal infection during screening. * Clinically significant hypokalemia (defined as serum potassium \<3.2 mmol/L, or below the lower limit of normal while receiving digitalis therapy) that cannot be corrected before starting trial treatment. * Hepatic dysfunction with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥5× upper limit of normal (ULN), or total bilirubin ≥3× ULN. * Renal impairment requiring or currently undergoing hemodialysis or peritoneal dialysis. * New York Heart Association (NYHA) Class III/IV heart failure. * Positive for human immunodeficiency virus (HIV) antibody or Treponema pallidum hemagglutination assay (TPHA). * Expected survival \<3 months. * Pregnant or breastfeeding women, or women of childbearing potential who are not using contraception and planning pregnancy. * Any other condition that the investigator considers inappropriate for participation in the clinical trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Haikou Affiliated Hospital of Central South University Xiangya School of Medicine
RECRUITINGHaikou, Hainan, 570208, China
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