Invasive Fungal DiseaseNCT07559032
Amphotericin B for Breakthrough Fungal Infections After Triazole Prophylaxis in Hematological Patients
A study testing Amphotericin B in people with Invasive Fungal Disease, run by Peking University People's Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Fungal Disease
- What is being tested?
- Amphotericin B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- Apr 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality
Rui Ma, +86 18834948122, marui_pku_ed@163.com
About this study
Official 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
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:
Read more
- What is the overall response rate (complete remission + partial remission) of amphotericin B in treating breakthrough IFD after azole prophylaxis?
- What medical problems do participants have when taking amphotericin B?
- What is the 6-week (42-day) overall survival rate after starting treatment?
This is a single-arm, prospective study. Participants will:
- Receive intravenous liposomal amphotericin B (3-5 mg/kg daily) for 4-6 weeks.
- Undergo weekly clinical and laboratory assessments, including serum G/GM tests, microbiology tests, and imaging (CT) at 2, 4, and 6 weeks.
- Have safety monitoring including liver and kidney function, electrolytes, and ECG.
- Be followed for treatment response and survival.
- Conditions
- Invasive Fungal Disease
- Being tested
- Amphotericin B
- Keywords
- Breakthrough fungal infection, Invasive fungal disease, Triazole prophylaxis, Amphotericin B, Hematological diseases
- Medical subject headings
- Invasive Fungal Infections, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amphotericin BDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Amphotericin B Treatment | Experimental | Not described Receives: Drug: Amphotericin B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate of Antifungal Therapy at 6 Weeks (42 Days)
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.
Measured: 6 weeks (42 days) after treatment initiation
Secondary outcomes (13)
Overall Survival Rate at 6 Weeks
Proportion of participants alive at 6 weeks (42 days) after initiation of amphotericin B therapy.
Measured: 6 weeks (42 days) after treatment initiation
Change in serum G test level
Change from baseline in serum (1,3)-β-D-glucan level. Unit of measure: pg/mL.
Measured: From enrollment to the end of 6-week treatment
Change in serum GM test level
Change from baseline in serum galactomannan test value. Unit of measure: ug/L.
Measured: From enrollment to the end of 6-week treatment
Microbiological clearance
Proportion of participants with negative conversion of baseline positive microbiological evidence (e.g., blood culture, sputum culture, mNGS, or site smear/culture).
Measured: From enrollment to the end of 6-week treatment
Change in chest CT findings
Change from baseline in chest CT lesion characteristics (e.g., reduction in size, new lesions, complete resolution).
Measured: Baseline to 6 weeks after treatment initiation
Proportion of participants with treatment-emergent adverse events (AEs)
Proportion of participants experiencing any AE, graded according to WHO toxicity criteria (grade 3 or higher AEs leading to drug discontinuation).
Measured: From first dose to 30 days after last dose.
Proportion of participants discontinuing amphotericin B due to adverse events
Proportion of participants who permanently stop amphotericin B because of any AE.
Measured: During treatment period (up to 6 weeks).
Change in serum alanine aminotransferase (ALT)
Change from baseline in ALT level. Unit of measure: U/L.
Measured: Baseline to end of treatment up to 6 weeks (twice weekly).
Change in serum aspartate aminotransferase (AST)
Change from baseline in AST level. Unit of measure: U/L.
Measured: Baseline to end of treatment up to 6 weeks (twice weekly).
Change in serum total bilirubin
Change from baseline in total bilirubin level. Unit of measure: μmol/L.
Measured: Baseline to end of treatment up to 6 weeks (twice weekly).
Change in serum creatinine
Description: Change from baseline in serum creatinine level. Unit of measure: μmol/L.
Measured: Baseline to end of treatment up to 6 weeks (twice weekly).
Change in serum electrolyte levels (potassium, sodium, calcium, magnesium)
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.
Measured: Baseline to end of treatment up to 6 weeks (twice weekly).
Change in electrocardiogram (ECG) findings
Change from baseline in ECG parameters (e.g., QTc interval).
Measured: Baseline to end of treatment up to 6 weeks (weekly).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Fungal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-Jun Huang, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559032
- Sponsor's protocol ID
- PKUPH20260411
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07559032
- Acronym / sponsor ID
- PKUPH20260411
- Conditions
- Invasive Fungal Disease
- Keywords
- Breakthrough fungal infection, Invasive fungal disease, Triazole prophylaxis, Amphotericin B, Hematological diseases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the overall response rate (complete remission + partial remission) of amphotericin B in treating breakthrough IFD after azole prophylaxis?
- What medical problems do participants have when taking amphotericin B?
- What is the 6-week (42-day) overall survival rate after starting treatment?
This is a single-arm, prospective study. Participants will:
- Receive intravenous liposomal amphotericin B (3-5 mg/kg daily) for 4-6 weeks.
- Undergo weekly clinical and laboratory assessments, including serum G/GM tests, microbiology tests, and imaging (CT) at 2, 4, and 6 weeks.
- Have safety monitoring including liver and kidney function, electrolytes, and ECG.
- Be followed for treatment response and survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amphotericin B Treatment | Experimental | Drug: Amphotericin B |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amphotericin BAmphotericin 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. | Drug | Amphotericin B Treatment |
Primary outcome
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.
13 secondary outcomes
Overall Survival Rate at 6 Weeks
Time frame: 6 weeks (42 days) after treatment initiation
Change in serum G test level
Time frame: From enrollment to the end of 6-week treatment
Change in serum GM test level
Time frame: From enrollment to the end of 6-week treatment
Microbiological clearance
Time frame: From enrollment to the end of 6-week treatment
Change in chest CT findings
Time frame: Baseline to 6 weeks after treatment initiation
Proportion of participants with treatment-emergent adverse events (AEs)
Time frame: From first dose to 30 days after last dose.
Proportion of participants discontinuing amphotericin B due to adverse events
Time frame: During treatment period (up to 6 weeks).
Change in serum alanine aminotransferase (ALT)
Time frame: Baseline to end of treatment up to 6 weeks (twice weekly).
Change in serum aspartate aminotransferase (AST)
Time frame: Baseline to end of treatment up to 6 weeks (twice weekly).
Change in serum total bilirubin
Time frame: Baseline to end of treatment up to 6 weeks (twice weekly).
Change in serum creatinine
Time frame: Baseline to end of treatment up to 6 weeks (twice weekly).
Change in serum electrolyte levels (potassium, sodium, calcium, magnesium)
Time frame: Baseline to end of treatment up to 6 weeks (twice weekly).
Change in electrocardiogram (ECG) findings
Time frame: Baseline to end of treatment up to 6 weeks (weekly).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amphotericin B in people with Invasive Fungal Disease, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rui Ma (+86 18834948122, marui_pku_ed@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate of Antifungal Therapy at 6 Weeks (42 Days) (time frame: 6 weeks (42 days) after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.