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

Invasive Fungal Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05116059
• Other study ID #: CSPC-ABCD-K02
• Status: Recruiting
• Start date: October 22, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: October 2022
• Source: Peking Union Medical College Hospital
• Contact: zhengyin Liu, PhD
• Phone: 010-69156114
• Email: zhengyinl[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Invasive Fungal Disease
• Invasive Fungal Infections
• Mycoses

Intervention

Drug:
• Amphotericin B colloidal dispersion(ABCD)
The dosage and course of ABCD were determined by clinicians, and this study was registered according to clinical practice

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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).