Clinical Study of ABCD in the Treatment of Cryptococcal Meningitis

• Status: Not yet recruiting
• Trial end date: 2023-04-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborator: CSPC Ouyi Pharmaceutical Group Co., Ltd.
• Treatments: Amphotericin B; Cholesteryl sulfate; Fluconazole; Flucytosine; Liposomal amphotericin B

Criteria

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.