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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Invasive Fungal Disease

Treatments: Drug: Amphotericin B colloidal dispersion（ABCD）

Study type: Observational

Funder types: Other

Identifiers

NCT05116059

CSPC-ABCD-K02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.