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

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.

Study Overview

• Status: Recruiting
• Conditions: Invasive Fungal Disease
• Intervention / Treatment: Drug: Amphotericin B colloidal dispersion（ABCD）

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Zhengyin Liu, PhD; Phone Number: 010-69156114; Email: zhengyinl@hotmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Zhengyin Liu, PhD; Phone Number: 010-69156114; Email: zhengyinl@hotmail.com
      • Principal Investigator: Zhengyin Liu, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with invasive fungal disease and accepted of ABCD

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Chair: zhengyin Liu, PhD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: November 1, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Actual): October 21, 2022
• Last Update Submitted That Met QC Criteria: October 20, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Amphotericin B Colloidal Dispersion; Invasive fungal disease
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Invasive Fungal Infections; Anti-Infective Agents; Anti-Bacterial Agents; Antifungal Agents; Antiprotozoal Agents; Antiparasitic Agents; Amebicides; Amphotericin B; Liposomal amphotericin B
• Other Study ID Numbers: CSPC-ABCD-K02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No