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

Recruiting

• Conditions: Invasive Fungal Disease

• Registration Number: NCT05116059
• Lead Sponsor: Peking Union Medical College Hospital

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.

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 Timeline

• Study First Submitted: 2021-10-12
• Study Start: 2021-10-22
• Study First Submitted QC: 2021-11-01
• Study First Posted: 2021-11-10
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-20
• Last Update Posted: 2022-10-21
• Primary Completion: 2022-12-31
• Study Completion: 2023-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
therapeutic response rate	within one week of the last administration of ABCD	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.
Infusion reaction, renal toxicity, hypokalemia, liver function and other adverse events [Safety and Tolerability]	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).	The incidence, start and end times, and severity of adverse events

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China