Can a safer dose of an old drug shield vulnerable children from deadly fungal infections?

NCT ID NCT07725263

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

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

3 to 17 years

Sex

Anyone

Healthy volunteers

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

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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Haikou Affiliated Hospital of Central South University Xiangya School of Medicine

    RECRUITING

    Haikou, Hainan, 570208, China

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