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

NCT05116059 | Unknown

• 1 other identifier: CSPC-ABCD-K02
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Invasive Fungal Disease

Keywords

Amphotericin B Colloidal Dispersion; Invasive fungal disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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).

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with invasive fungal disease and accepted of ABCD

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40384797 DERIVED

MeSH Terms

Conditions

Invasive Fungal Infections

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Study Officials

• zhengyin Liu, PhD

  Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

zhengyin Liu, PhD

CONTACT

010-69156114; zhengyinl@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: November 10, 2021
• Study Start: October 22, 2021
• Primary Completion: December 31, 2022
• Study Completion: January 31, 2023
• Last Updated: October 21, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)