An interventional study of Amphotericin B in Invasive Fungal Disease, sponsored by Peking University People's Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment
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:
This is a single-arm, prospective study. Participants will:
136 studies on the registry are indexed under Invasive Fungal Infections; 33 are open to participants now.
This study's planned enrollment of 15 is below the median of 70 across 67 interventional studies indexed under Invasive Fungal Infections.
Browse Invasive Fungal Infections studies →Peking University People's Hospital is the lead sponsor of 609 studies on the registry; 247 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Amphotericin B
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.
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.
Time frame: 6 weeks (42 days) after treatment initiation
Overall Survival Rate at 6 Weeks
Proportion of participants alive at 6 weeks (42 days) after initiation of amphotericin B therapy.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: During treatment period (up to 6 weeks).
Change in serum alanine aminotransferase (ALT)
Change from baseline in ALT level. Unit of measure: U/L.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline to end of treatment up to 6 weeks (weekly).
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Amphotericin B
Peking University People's Hospital →