NCT06376201

A Clinical Study on the Efficacy and Safety of ABCD in the Treatment of Patients With Invasive Fungal Disease

A Clinical Study on the Efficacy and Safety of Amphotericin B Cholesteryl Sulfate Complex for Injection in the Empirical First-line Treatment of Patients With Invasive Fungal Diseases

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, multicenter, single-arm study, that aims to evaluate the efficacy and safety of amphotericin B cholesterol-sulfate complex (ABCD) for injection in the first-line treatment of patients with invasive fungal diseases, hoping to provide a reference for the clinical treatment of invasive fungal diseases. Patients with hematologic diseases who meet the criteria for inclusion and discharge with febrile neutropenia and suspected fungal infection were treated with ABCD antifungal therapy for 14 days while receiving treatment for underlying diseases, and the response rate of treatment was observed.

Conditions

• Invasive Fungal Disease

Interventions

Type	Name	Description
DRUG	Amphotericin B cholesterol-sulfate complex for injection	Patients were eligible for enrollment on antifungal therapy with injectable amphotericin B cholesterol-sulfate complex (ABCD) at the same time as a treatment for underlying disease. Dosage: According to the patient's condition and the investigator's judgment, the initial dose of ABCD can be 0.5-1.0mg/kg/d, and the dose can be increased daily according to the situation, and the therapeutic dose can be increased to 3.0-4.0mg/kg/d on the third day. Course of treatment: ≥ 14 days (whether to continue to receive trial drug treatment after 14 days is decided by the investigator according to the patient's condition).

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-02-01
• Completion: 2025-09-01
• First posted: 2024-04-19
• Last updated: 2024-04-19