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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05116059
Other study ID # CSPC-ABCD-K02
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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).
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