Invasive Fungal InfectionsNCT07532850
Study on the Pharmacokinetic Characteristics of Liposomal Amphotericin B in Patients With Invasive Fungal Infections Undergoing Plasma Exchange Therapy
An observational study of Invasive Fungal Infections, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
The goal of this prospective study is to describe the pharmacokinetic characteristics of liposomal amphotericin B during plasma exchange therapy for severe invasive fungal infections in Chinese patients, preliminarily explore the influencing factors of in vivo exposure variability of liposomal amphotericin B, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Fungal Infections
- What is being tested?
- Collection of pharmacokinetic samples to explore the pharmacokinetic characteristics in severe invasive fungal infection patients receive liposomal amphotericin B who undergo plasma exchange therapy.
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2026to 30 Jun 2027
- Phase
- Observational
- 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
Study population: critically ill patients with invasive fungal infections undergoing plasma exchange therapy who receive liposomal amphotericin B therapy
Who may be able to join
- Age ≥ 18 years old, gender not limited; According to < The Chinese guidelines for the diagnosis and treatment of invasive fungal disease in patients with hematological disorders and cancers (the 6th revision) >, the diagnosis is neutropenia with fever, possible, probable, and proven IFD invasive fungal disease;
- Currently receiving treatment with liposomal amphotericin B;
- Undertaking plasma exchange support therapy;
- Understand the research procedure and voluntarily sign a written informed consent form.
Who cannot join
- Confirmed patients with allergies/rapid onset severe allergic reactions/intolerance to AmB Subjects who are known to be insensitive or resistant to amphotericin B treatment, such as those with invasive Aspergillus terreus and Aspergillus nidulans
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study on the Pharmacokinetic Characteristics, Safety, and Efficacy of Liposomal Amphotericin B in Critically Ill Patients With Invasive Fungal Infections Undergoing Plasma Exchange Therapy
The goal of this prospective study is to describe the pharmacokinetic characteristics of liposomal amphotericin B during plasma exchange therapy for severe invasive fungal infections in Chinese patients, preliminarily explore the influencing factors of in vivo exposure variability of liposomal amphotericin B, and integrate the findings with efficacy and safety outcomes.
The main questions it aims to answer is: Clarifying the correlation between the concentration, efficacy, and safety of different forms of liposomal amphotericin B in a special population, explore the changes in drug concentration mediated by plasma exchange, elucidate the mechanism of individual differences in efficacy and the optimal dosage, in order to provide a basis for personalized treatment of liposomal amphotericin B.
The study plans to collect pharmacokinetic samples from 10 adult (aged ≥ 18 years) severe invasive fungal infection patients receive liposomal amphotericin B who undergo plasma exchange therapy.
Read the detailed description
- Establishment of UPLC-MS/MS（Ultra Performance Liquid Chromatography-Tandem Mass Spectrometry） analysis method for amphotericin B in plasma. Due to various factors such as small sample size, low drug concentration, endogenous substance interference, and individual differences that affect the determination of in vivo samples, in order to ensure the reliability of the method, it is necessary to validate the method while establishing an in vivo sample analysis method. By systematically optimizing plasma sample pretreatment, chromatographic conditions, and mass spectrometry conditions, and conducting methodological investigations on specificity, minimum quantification limit, minimum detection limit, linear range, accuracy, precision, matrix effects, stability system, etc., an accurate, rapid, and highly sensitive UPLC-MS/MS method is established.
- Study on the pharmacokinetic characteristics of amphotericin B liposomes in patients with severe invasive fungal infections undergoing plasma exchange therapy using traditional Chinese medicine Research subjects: The research subjects of this project are patients with severe invasive fungal infections receiving plasma exchange therapy. Plan to include 10 people. When the patient's dosage is stable, collect 4mL of intravenous blood from the EDTA-K2（Ethylenediaminetetraacetic acid dipotassium salt） collection tube within 1 hour before the administration of liposomal amphotericin B before plasma exchange, immediately after infusion, 1 hour, 6 hours, 12 hours after infusion, 5 minutes before and immediately after plasma exchange, immediately after the next infusion after plasma exchange, and 24 hours. Subsequent pharmacokinetic studies will be conducted.
- Optimization of treatment plan for severe invasive fungal infections in patients receiving plasma exchange therapy with liposomal amphotericin B
- Conditions
- Invasive Fungal Infections
- Being tested
- Collection of pharmacokinetic samples to explore the pharmacokinetic characteristics in severe invasive fungal infection patients receive liposomal amphotericin B who undergo plasma exchange therapy.
- Keywords
- plasma exchange, invasive fungal infection, liposomal amphotericin B, pharmacokinetics
- Medical subject headings
- Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of pharmacokinetic samples to explore the pharmacokinetic characteristics in severe invasive fungal infection patients receive liposomal amphotericin B who undergo plasma exchange therapy.Other
Collection of pharmacokinetic samples to explore the pharmacokinetic characteristics in severe invasive fungal infection patients receive liposomal amphotericin B who undergo plasma exchange therapy.
| Study group | Role | What they receive |
|---|---|---|
| invasive fungal infection patients | Severe invasive fungal infection patients receive liposomal amphotericin B who undergo plasma exchange therapy Receives: Other: Collection of pharmacokinetic samples to explore the pharmacokinetic characteristics in severe invasive fungal infection patients receive liposomal amphotericin B who undergo plasma exchange therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic characteristics of liposomal amphotericin B in patients with severe invasive fungal infections undergoing plasma exchange therapy.
Pharmacokinetic characteristics of liposomal amphotericin B in patients with severe invasive fungal infections undergoing plasma exchange therapy.
Plot the concentration time data and mean values of amphotericin B from different time samples of each patient, along with a list of standard deviations. Using a non-compartmental model method, fit the drug time data of each patient and component using Phoenix WinNonlin software. Calculate the following pharmacokinetic parameters, mean values, and standard deviations:
- Maximum blood drug concentration (Cmax)
Measured: through study completion, an average of 2 years
Secondary outcomes (4)
Pharmacokinetic characteristics of liposomal amphotericin B in patients with severe invasive fungal infections undergoing plasma exchange therapy.
Pharmacokinetic characteristics of liposomal amphotericin B in patients with severe invasive fungal infections undergoing plasma exchange therapy.
Plot the concentration time data and mean values of amphotericin B from different time samples of each patient, along with a list of standard deviations. Using a non-compartmental model method, fit the drug time data of each patient and component using Phoenix WinNonlin software. Calculate the following pharmacokinetic parameters, mean values, and standard deviations:
- Blood drug concentration before next administration (Ctrough)
Measured: Through study completion, an average of 2 years
Time to reach maximum blood drug concentration
Pharmacokinetic characteristics of liposomal amphotericin B in patients with severe invasive fungal infections undergoing plasma exchange therapy.
Plot the concentration time data and mean values of amphotericin B from different time samples of each patient, along with a list of standard deviations. Using a non-compartmental model method, fit the drug time data of each patient and component using Phoenix WinNonlin software. Calculate the following pharmacokinetic parameters, mean values, and standard deviations:
- Time to reach maximum blood drug concentration (Tmax)
Measured: Through study completion, an average of 2 years
the area under the blood drug concentration time curve during the dosing cycle and up to infinity
Pharmacokinetic characteristics of liposomal amphotericin B in patients with severe invasive fungal infections undergoing plasma exchange therapy.
Plot the concentration time data and mean values of amphotericin B from different time samples of each patient, along with a list of standard deviations. Using a non-compartmental model method, fit the drug time data of each patient and component using Phoenix WinNonlin software. Calculate the following pharmacokinetic parameters, mean values, and standard deviations:
The area under the blood drug concentration time curve during the dosing cycle and up to infinity (AUC0- τ and AUC 0- ∞, respectively)
Measured: Through study completion, an average of 2 years
Terminal elimination of half-life
Pharmacokinetic characteristics of liposomal amphotericin B in patients with severe invasive fungal infections undergoing plasma exchange therapy.
Plot the concentration time data and mean values of amphotericin B from different time samples of each patient, along with a list of standard deviations. Using a non-compartmental model method, fit the drug time data of each patient and component using Phoenix WinNonlin software. Calculate the following pharmacokinetic parameters, mean values, and standard deviations:
Terminal elimination half-life (t1/2)
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start30 Mar 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Fungal InfectionsStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532850
- Sponsor's protocol ID
- QTJC2025008
- Status last verified
- Apr 2026
- First submitted
- 27 Feb 2026
- Last updated
- 16 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 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Pharmacokinetic Characteristics, Safety, and Efficacy of Liposomal Amphotericin B in Critically Ill Patients With Invasive Fungal Infections Undergoing Plasma Exchange Therapy
- ClinicalTrials.gov ID
- NCT07532850
- Acronym / sponsor ID
- QTJC2025008
- Conditions
- Invasive Fungal Infections
- Keywords
- plasma exchange, invasive fungal infection, liposomal amphotericin B, pharmacokinetics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 16 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 prospective study is to describe the pharmacokinetic characteristics of liposomal amphotericin B during plasma exchange therapy for severe invasive fungal infections in Chinese patients, preliminarily explore the influencing factors of in vivo exposure variability of liposomal amphotericin B, and integrate the findings with efficacy and safety outcomes.
The main questions it aims to answer is: Clarifying the correlation between the concentration, efficacy, and safety of different forms of liposomal amphotericin B in a special population, explore the changes in drug concentration mediated by plasma exchange, elucidate the mechanism of individual differences in efficacy and the optimal dosage, in order to provide a basis for personalized treatment of liposomal amphotericin B.
The study plans to collect pharmacokinetic samples from 10 adult (aged ≥ 18 years) severe invasive fungal infection patients receive liposomal amphotericin B who undergo plasma exchange therapy.
Detailed description
- Establishment of UPLC-MS/MS（Ultra Performance Liquid Chromatography-Tandem Mass Spectrometry） analysis method for amphotericin B in plasma. Due to various factors such as small sample size, low drug concentration, endogenous substance interference, and individual differences that affect the determination of in vivo samples, in order to ensure the reliability of the method, it is necessary to validate the method while establishing an in vivo sample analysis method. By systematically optimizing plasma sample pretreatment, chromatographic conditions, and mass spectrometry conditions, and conducting methodological investigations on specificity, minimum quantification limit, minimum detection limit, linear range, accuracy, precision, matrix effects, stability system, etc., an accurate, rapid, and highly sensitive UPLC-MS/MS method is established.
- Study on the pharmacokinetic characteristics of amphotericin B liposomes in patients with severe invasive fungal infections undergoing plasma exchange therapy using traditional Chinese medicine Research subjects: The research subjects of this project are patients with severe invasive fungal infections receiving plasma exchange therapy. Plan to include 10 people. When the patient's dosage is stable, collect 4mL of intravenous blood from the EDTA-K2（Ethylenediaminetetraacetic acid dipotassium salt） collection tube within 1 hour before the administration of liposomal amphotericin B before plasma exchange, immediately after infusion, 1 hour, 6 hours, 12 hours after infusion, 5 minutes before and immediately after plasma exchange, immediately after the next infusion after plasma exchange, and 24 hours. Subsequent pharmacokinetic studies will be conducted.
- Optimization of treatment plan for severe invasive fungal infections in patients receiving plasma exchange therapy with liposomal amphotericin B
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| invasive fungal infection patients | – | Other: Collection of pharmacokinetic samples to explore the pharmacokinetic characteristics in severe invasive fungal infection patients receive liposomal amphotericin B who undergo plasma exchange therapy.Severe invasive fungal infection patients receive liposomal amphotericin B who undergo plasma exchange therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- critically ill patients with invasive fungal infections undergoing plasma exchange therapy who receive liposomal amphotericin B therapy
Key inclusion criteria (4 listed)
- Age ≥ 18 years old, gender not limited; According to < The Chinese guidelines for the diagnosis and treatment of invasive fungal disease in patients with hematological disorders and cancers (the 6th revision) >, the diagnosis is neutropenia with fever, possible, probable, and proven IFD invasive fungal disease;
- Currently receiving treatment with liposomal amphotericin B;
- Undertaking plasma exchange support therapy;
- Understand the research procedure and voluntarily sign a written informed consent form.
Key exclusion criteria (2 listed)
- Confirmed patients with allergies/rapid onset severe allergic reactions/intolerance to AmB Subjects who are known to be insensitive or resistant to amphotericin B treatment, such as those with invasive Aspergillus terreus and Aspergillus nidulans
- -
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 |
|---|---|---|
| Collection of pharmacokinetic samples to explore the pharmacokinetic characteristics in severe invasive fungal infection patients receive liposomal amphotericin B who undergo plasma exchange therapy.Collection of pharmacokinetic samples to explore the pharmacokinetic characteristics in severe invasive fungal infection patients receive liposomal amphotericin B who undergo plasma exchange therapy. | Other | invasive fungal infection patients |
Primary outcome
Pharmacokinetic characteristics of liposomal amphotericin B in patients with severe invasive fungal infections undergoing plasma exchange therapy.
Time frame: through study completion, an average of 2 years
Pharmacokinetic characteristics of liposomal amphotericin B in patients with severe invasive fungal infections undergoing plasma exchange therapy. Plot the concentration time data and mean values of amphotericin B from different time samples of each patient, along with a list of standard deviations. Using a non-compartmental model method, fit the drug time data of each patient and component using Phoenix WinNonlin software. Calculate the following pharmacokinetic parameters, mean values, and standard deviations: • Maximum blood drug concentration (Cmax)
4 secondary outcomes
Pharmacokinetic characteristics of liposomal amphotericin B in patients with severe invasive fungal infections undergoing plasma exchange therapy.
Time frame: Through study completion, an average of 2 years
Time to reach maximum blood drug concentration
Time frame: Through study completion, an average of 2 years
the area under the blood drug concentration time curve during the dosing cycle and up to infinity
Time frame: Through study completion, an average of 2 years
Terminal elimination of half-life
Time frame: Through study completion, an average of 2 years
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 16 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Fungal Infections, run by Institute of Hematology & Blood Diseases Hospital, 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 2 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 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 wenjuan miao, Doctor (+86 18622691362, miaowenjuan@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic characteristics of liposomal amphotericin B in patients with severe invasive fungal infections undergoing plasma exchange therapy. (time frame: through study completion, an average of 2 years). 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 16 Apr 2026.