Clinical Study of ABCD in the Treatment of Cryptococcal Meningitis

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Not yet enrolling

Conditions: Cryptococcal Meningitis

Treatments: Drug: fluconazole; Drug: Amphotericin B Colloidal Dispersion; Drug: flucytosine

Study type: Interventional

Funder types: Other

Identifiers

NCT05471063

CSPC-ABCD-K09

Details and patient eligibility

About

To evaluate the efficacy and safety of ABCD in the treatment of cryptococcal meningitis in non-HIV patients at week 4, the end of induction therapy, week 10 and the end of consolidation therapy.

Full description

This study is a multi-center, single-arm clinical study. The objective is to evaluate the efficacy and safety of ABCD in the treatment of cryptococcal meningitis in non-HIV patients. Qualified subjects shall receive cryptococcus induction therapy with ABCD combined with flucytosine for at least 4 weeks, or termination of treatment early at the investigator's discretion. Efficacy and safety are followed up at week 4 (day 28), the end of induction therapy, week 10 (day 70) and the end of consolidation therapy.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥18 years old and ≤70 years old, no gender limitation;
• Diagnosis of cryptococcal meningitis (with or without other cryptococcal lesions) based on CSF culture and/or CSF ink staining smear and/or CSF antigen testing;
• The researcher believes that patients can benefit from participating in this study;
• The subjects voluntarily participated in the study and signed the informed consent.

Exclusion criteria

• Patients with other invasive fungal diseases;
• HIV infected patients;
• Patients who received intravenous polyene treatment within the past 6 months;
• Allergic to Amphotericin B Colloidal Dispersion or other ingredients in this product;
• Patients with abnormal liver function [aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >＝5 times the upper limit of normal value (ULN) without total bilirubin elevation, or ALT or AST >＝ 3 times ULN with total bilirubin >＝ 1.5 times];
• Patients with impaired renal function (renal function index blood creatinine (Cr) is more than 2 times higher than ULN, or 24-hour urine creatinine clearance rate （Ccr） is less than 50ml/min), or patients requiring/undergoing hemodialysis or peritoneal dialysis;
• Pregnant women, breast-feeding women and women of childbearing age who were unable to take effective contraceptive measures during the study period;
• Conditions considered unsuitable for the study by the investigator, such as concomitancy of severe organ insufficiency, clinically significant laboratory abnormalities, comprehension or compliance problems, etc.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

ABCD treatment

Experimental group

Description:

In this single-arm research, patients were treated with ABCD 3.0-4.0 mg/kg/d (subject to adjustment, maximum dose not exceeding 6.0 mg/kg/d) combined with flucytosine 100 mg/kg/d for induction therapy of cryptococcal meningitis. The course of induction therapy is at least four weeks. Then, patients were treated with Fluconazole (400-600 mg/d) ± flucytosine (100 mg/kg/d) for consolidation therapy for at least 6 weeks.

Treatment:

Drug: flucytosine

Drug: Amphotericin B Colloidal Dispersion

Drug: fluconazole