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Can a Low-Dose antifungal shield vulnerable patients from deadly fungal infections?

NCT ID NCT07763054

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This study looks at whether a low dose of the antifungal drug liposomal amphotericin B can prevent serious fungal infections in adults with blood cancers or who have had stem cell transplants and have a prolonged low white blood cell count (neutropenia). The trial enrolls 30 patients aged 18-75 who are already receiving this drug as part of their routine care because they cannot tolerate other antifungals. Researchers will track how many develop a proven or probable fungal infection, as well as side effects, to see if this preventive approach is both safe and effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Liposomal amphotericin B (an antifungal drug given intravenously at a low dose)
What this could lead to
If effective, this low-dose approach could offer a safer way to prevent life-threatening fungal infections in people with weakened immune systems from blood cancers or stem cell transplants.
What could go wrong
This is a small, single-arm study, so results may not be conclusive. The drug can still cause side effects, and the low dose might not be enough to prevent infections in all patients.

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

Aug 2025

Expected to finish

Nov 2026

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

Adult patients (aged 18-75 years) with hematological malignancies who meet NCCN 2025 V1 high-risk criteria for invasive fungal disease, with expected neutropenia \>7 days (absolute neutrophil count ≤0.5×10⁹/L), who have been initiated on liposomal amphotericin B prophylaxis at 50 mg/day by the treating physician in routine clinical practice due to intolerance or toxicity to other antifungal agents.

Ages

18 to 75 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 18 to 75 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, multiple myeloma, chronic lymphocytic leukemia, treatment with purine analogues (fludarabine, clofarabine, nelarabine), chimeric antigen receptor (CAR) T-cell therapy, alemtuzumab therapy, with expected neutropenia \>7 days and accompanied by agranulocytosis. Note: 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 50 mg/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.

  1. The places running it

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

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

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

    RECRUITING

    Hainan, Hainan, 570208, China

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