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NCT Number: NCT07559032

Amphotericin B for Breakthrough Fungal Infections After Triazole Prophylaxis in Hematological Patients

The goal of this clinical trial is to learn if amphotericin B works to treat breakthrough invasive fungal disease (IFD) in patients with hematological diseases who have received azole-based prophylaxis. It will also learn about the safety of amphotericin B in this population.

The main questions it aims to answer are:

1. What is the overall response rate (complete remission + partial remission) of amphotericin B in treating breakthrough IFD after azole prophylaxis? 2. What medical problems do participants have when taking amphotericin B? 3. What is the 6-week (42-day) overall survival rate after starting treatment?

This is a single-arm, prospective study. Participants will:

1. Receive intravenous liposomal amphotericin B (3-5 mg/kg daily) for 4-6 weeks. 2. Undergo weekly clinical and laboratory assessments, including serum G/GM tests, microbiology tests, and imaging (CT) at 2, 4, and 6 weeks. 3. Have safety monitoring including liver and kidney function, electrolytes, and ECG. 4. Be followed for treatment response and survival.

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Key information

Conditions

Invasive Fungal Disease Bacterial Infections and Mycoses Hematologic Diseases Hemic and Lymphatic Diseases Infections Invasive Fungal Infections Mycoses

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years old.
  • Diagnosed with hematological diseases and receiving triazole prophylaxis.
  • Confirmed or suspected breakthrough invasive fungal disease (IFD) according to EORTC/MSG 2020 criteria.
  • Able to understand and sign the informed consent form voluntarily.

Exclusion criteria

  • Severe liver or renal dysfunction (ALT/AST > 3×ULN, Cr > 2×ULN).
  • Known allergy to amphotericin B or any component of the study drug.
  • Pregnant or lactating women.
  • Severe underlying diseases with expected survival < 3 months.

Treatment and study plan

Amphotericin B

Drug

Amphotericin B is a polyene antifungal drug used to treat breakthrough fungal infections. The dosage and duration will be determined based on pathogen results and clinical guidelines.

Primary outcomes

  1. Overall Response Rate of Antifungal Therapy at 6 Weeks (42 Days)

    Time frame: 6 weeks (42 days) after treatment initiation

    The overall response rate will be assessed at 6 weeks (42 days) after the initiation of amphotericin B treatment, evaluated according to the EORTC/MSG 2020 criteria for invasive fungal disease, including complete response, partial response, stable disease, and progressive disease.

Secondary outcomes

  1. Overall Survival Rate at 6 Weeks

    Time frame: 6 weeks (42 days) after treatment initiation

    Proportion of participants alive at 6 weeks (42 days) after initiation of amphotericin B therapy.

  2. Change in serum G test level

    Time frame: From enrollment to the end of 6-week treatment

    Change from baseline in serum (1,3)-β-D-glucan level. Unit of measure: pg/mL.

  3. Change in serum GM test level

    Time frame: From enrollment to the end of 6-week treatment

    Change from baseline in serum galactomannan test value. Unit of measure: ug/L.

  4. Microbiological clearance

    Time frame: From enrollment to the end of 6-week treatment

    Proportion of participants with negative conversion of baseline positive microbiological evidence (e.g., blood culture, sputum culture, mNGS, or site smear/culture).

  5. Change in chest CT findings

    Time frame: Baseline to 6 weeks after treatment initiation

    Change from baseline in chest CT lesion characteristics (e.g., reduction in size, new lesions, complete resolution).

  6. Proportion of participants with treatment-emergent adverse events (AEs)

    Time frame: From first dose to 30 days after last dose.

    Proportion of participants experiencing any AE, graded according to WHO toxicity criteria (grade 3 or higher AEs leading to drug discontinuation).

  7. Proportion of participants discontinuing amphotericin B due to adverse events

    Time frame: During treatment period (up to 6 weeks).

    Proportion of participants who permanently stop amphotericin B because of any AE.

  8. Change in serum alanine aminotransferase (ALT)

    Time frame: Baseline to end of treatment up to 6 weeks (twice weekly).

    Change from baseline in ALT level. Unit of measure: U/L.

  9. Change in serum aspartate aminotransferase (AST)

    Time frame: Baseline to end of treatment up to 6 weeks (twice weekly).

    Change from baseline in AST level. Unit of measure: U/L.

  10. Change in serum total bilirubin

    Time frame: Baseline to end of treatment up to 6 weeks (twice weekly).

    Change from baseline in total bilirubin level. Unit of measure: μmol/L.

  11. Change in serum creatinine

    Time frame: Baseline to end of treatment up to 6 weeks (twice weekly).

    Description: Change from baseline in serum creatinine level. Unit of measure: μmol/L.

  12. Change in serum electrolyte levels (potassium, sodium, calcium, magnesium)

    Time frame: Baseline to end of treatment up to 6 weeks (twice weekly).

    Change from baseline in serum levels of potassium, sodium, calcium, and magnesium. Each electrolyte will be reported separately as absolute change (mmol/L) from baseline.

  13. Change in electrocardiogram (ECG) findings

    Time frame: Baseline to end of treatment up to 6 weeks (weekly).

    Change from baseline in ECG parameters (e.g., QTc interval).

Study contacts

Contact information is provided by the study sponsor or research team.

Rui Ma

CONTACT

[email protected]

+86 18834948122

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

A Multicenter, Prospective, Observational Study to Evaluate the Efficacy and Safety of Amphotericin B in the Treatment of Breakthrough Invasive Fungal Disease in Hematological Patients Receiving Triazole Prophylaxis

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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