To Evaluate the Efficacy and Safety of ABCD in the Treatment of IFD

NCT ID: NCT05116059

Last Updated: 2022-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-22

Study Completion Date

2023-01-31

Brief Summary

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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

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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

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Invasive Fungal Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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Amphotericin B colloidal dispersion(ABCD)

The dosage and course of ABCD were determined by clinicians, and this study was registered according to clinical practice

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18 years.
2. Patients with possible/probable/proven invasive fungal disease according to EORTC-MSG diagnostic criteria.
3. Patients received ABCD alone or in combination with other antifungals on either empirical, diagnosis-driven or targeted therapy.
4. There is no limit to the patient's previous treatment plan.

Exclusion Criteria

1. Patients judged by clinicians to be unsuitable for this study.
2. Patients with incomplete data or other factors affecting the judgment of efficacy and safety.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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zhengyin Liu, PhD

Role: STUDY_CHAIR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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zhengyin Liu, PhD

Role: CONTACT

010-69156114

Facility Contacts

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Zhengyin Liu, PhD

Role: primary

010-69156114

References

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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.

Reference Type DERIVED
PMID: 40384797 (View on PubMed)

Other Identifiers

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CSPC-ABCD-K02

Identifier Type: -

Identifier Source: org_study_id

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