Invasive Fungal DiseaseNCT05116059
To Evaluate the Efficacy and Safety of ABCD in the Treatment of IFD
An observational study of Invasive Fungal Disease, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
In order to better guide clinical medication, verify the efficacy and safety of ABCD in the treatment of various invasive fungal disease, the investigators have designed a multi-center, retrospective registration study. 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 colloidal dispersion（ABCD）
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 22 Oct 2021to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with invasive fungal disease and accepted of ABCD
Who may be able to join
- Age ≥18 years.
- Patients with possible/probable/proven invasive fungal disease according to EORTC-MSG diagnostic criteria.
- Patients received ABCD alone or in combination with other antifungals on either empirical, diagnosis-driven or targeted therapy.
- There is no limit to the patient's previous treatment plan.
Who cannot join
- Patients judged by clinicians to be unsuitable for this study.
- Patients with incomplete data or other factors affecting the judgment of efficacy and safety.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Zhengyin Liu, PhD, 010-69156114, zhengyinl@hotmail.com
Zhengyin Liu, PhD
About this study
Official title: To Evaluate the Efficacy and Safety of Amphotericin B Colloidal Dispersion (ABCD) in the Treatment of Invasive Fungal Disease: a Multicenter, Retrospective, Observational, Non-interventional Registration Study
In order to better guide clinical medication, verify the efficacy and safety of ABCD in the treatment of various invasive fungal disease, the investigators have designed a multi-center, retrospective registration study. Diagnosis and treatment data for patients with different types of invasive fungal disease in clinical actual environment was collapsed by a database for collaborative exchange on antifungal research.
Read the detailed description
This study is a retrospective, non-interventional, and observational study. The clinical data of the patient during hospitalization shall be collected at least 2 weeks after the end of the ABCD drug, including basic data of the patient, laboratory data and clinical treatment, mainly covering antifungal medications, such as pretreatment measures, drug dosage and dispensing method, route of administration, duration of administration, efficacy and adverse reactions, etc. If adverse events related to ABCD have not ended after 2 weeks, investigators are advised to follow up until the adverse events recover or stabilize. It is hoped that the basic situation of Chinese invasive fungal patients is described, and ABCD is evaluated in the treatment of invasive fungal patients. In addition, prognostic factors can be analyzed to optimize clinical medication regimen and provide basis support for clinical medication of ABCD.
- Conditions
- Invasive Fungal Disease
- Being tested
- Amphotericin B colloidal dispersion（ABCD）
- Keywords
- Amphotericin B Colloidal Dispersion, Invasive fungal disease
- 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.
Amphotericin B colloidal dispersion（ABCD）Drug
The dosage and course of ABCD were determined by clinicians, and this study was registered according to clinical practice
What is being measured
The primary outcome is the main question the study is designed to answer.
therapeutic response rate
Patients with hematological tumors are evaluated for efficacy according to the diagnostic criteria and treatment principles for invasive mycoses in patients with hematological diseases/malignant tumors (the sixth revised edition). Efficacy assessment criteria for patients with non-hematological tumors are defined as complete and partial response as effective, and stable, progress and death as ineffective.
Measured: within one week of the last administration of ABCD
Infusion reaction, renal toxicity, hypokalemia, liver function and other adverse events [Safety and Tolerability]
The incidence, start and end times, and severity of adverse events
Measured: from the date of start medication until the date of last dose of ABCD. If the adverse reaction has not ended after 2 weeks, clinicians are advised to follow up until the adverse event has recovered or stabilized (Assessed up to 1 week).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start22 Oct 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Invasive Fungal DiseaseStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- zhengyin Liu, PhD, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116059
- Sponsor's protocol ID
- CSPC-ABCD-K02
- Status last verified
- Oct 2022
- First submitted
- 12 Oct 2021
- Last updated
- 21 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang L, Zhang Q, Ma W, Chu ZB, Xu L, Xing H, Wang J, Lin J, Liu Z. Efficacy and Safety of Amphotericin B Colloidal Dispersion for Patients with Invasive Fungal Disease and Febrile Neutropenia: A Registry-Based, Multicenter, Retrospective, Real-World Study. Infect Drug Resist. 2025 May 13;18:2475-2487. doi: 10.2147/IDR.S494985. eCollection 2025.
PubMed 40384797
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Efficacy and Safety of Amphotericin B Colloidal Dispersion (ABCD) in the Treatment of Invasive Fungal Disease: a Multicenter, Retrospective, Observational, Non-interventional Registration Study
- ClinicalTrials.gov ID
- NCT05116059
- Acronym / sponsor ID
- CSPC-ABCD-K02
- Conditions
- Invasive Fungal Disease
- Keywords
- Amphotericin B Colloidal Dispersion, Invasive fungal disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 10 Nov 2021 (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.
In order to better guide clinical medication, verify the efficacy and safety of ABCD in the treatment of various invasive fungal disease, the investigators have designed a multi-center, retrospective registration study. Diagnosis and treatment data for patients with different types of invasive fungal disease in clinical actual environment was collapsed by a database for collaborative exchange on antifungal research.
Detailed description
This study is a retrospective, non-interventional, and observational study. The clinical data of the patient during hospitalization shall be collected at least 2 weeks after the end of the ABCD drug, including basic data of the patient, laboratory data and clinical treatment, mainly covering antifungal medications, such as pretreatment measures, drug dosage and dispensing method, route of administration, duration of administration, efficacy and adverse reactions, etc. If adverse events related to ABCD have not ended after 2 weeks, investigators are advised to follow up until the adverse events recover or stabilize. It is hoped that the basic situation of Chinese invasive fungal patients is described, and ABCD is evaluated in the treatment of invasive fungal patients. In addition, prognostic factors can be analyzed to optimize clinical medication regimen and provide basis support for clinical medication of ABCD.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with invasive fungal disease and accepted of ABCD
Key inclusion criteria (4 listed)
- Age ≥18 years.
- Patients with possible/probable/proven invasive fungal disease according to EORTC-MSG diagnostic criteria.
- Patients received ABCD alone or in combination with other antifungals on either empirical, diagnosis-driven or targeted therapy.
- There is no limit to the patient's previous treatment plan.
Key exclusion criteria (2 listed)
- Patients judged by clinicians to be unsuitable for this study.
- Patients with incomplete data or other factors affecting the judgment of efficacy and safety.
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 B colloidal dispersion（ABCD）The dosage and course of ABCD were determined by clinicians, and this study was registered according to clinical practice | Drug | – |
Primary outcome
therapeutic response rate
Time frame: within one week of the last administration of ABCD
Patients with hematological tumors are evaluated for efficacy according to the diagnostic criteria and treatment principles for invasive mycoses in patients with hematological diseases/malignant tumors (the sixth revised edition). Efficacy assessment criteria for patients with non-hematological tumors are defined as complete and partial response as effective, and stable, progress and death as ineffective.
Infusion reaction, renal toxicity, hypokalemia, liver function and other adverse events [Safety and Tolerability]
Time frame: from the date of start medication until the date of last dose of ABCD. If the adverse reaction has not ended after 2 weeks, clinicians are advised to follow up until the adverse event has recovered or stabilized (Assessed up to 1 week).
The incidence, start and end times, and severity of adverse events
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- Derived from this study: PubMed 40384797Zhang L, Zhang Q, Ma W, Chu ZB, Xu L, Xing H, Wang J, Lin J, Liu Z. Efficacy and Safety of Amphotericin B Colloidal Dispersion for Patients with Invasive Fungal Disease and Febrile Neutropenia: A Registry-Based, Multicenter, Retrospective, Real-World Study. Infect Drug Resist. 2025 May 13;18:2475-2487. doi: 10.2147/IDR.S494985. eCollection 2025.
- 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. This study is not recruiting at the moment.
zhengyin Liu, PhD study chair
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Fungal Disease, run by Peking Union Medical College 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 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: status not confirmed, as of the sponsor's last update on 21 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zhengyin Liu, PhD (010-69156114, zhengyinl@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
therapeutic response rate (time frame: within one week of the last administration of ABCD). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05116059, which also lists 1 linked publication.
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 21 Oct 2022.