Clinical Study of ABCD in the Treatment of Cryptococcal Meningitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-22

Study Completion Date

2023-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cryptococcal Meningitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ABCD treatment

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.

Group Type EXPERIMENTAL

Amphotericin B Colloidal Dispersion

Intervention Type DRUG

Amphotericin B Colloidal Dispersion 3.0-4.0 mg/kg/d (subject to adjustment, maximum dose not exceeding 6.0 mg/kg/d) . The course of induction therapy is at least four weeks.

flucytosine

Intervention Type DRUG

Flucytosine 100 mg/kg/d for induction therapy and consolidation therapy of cryptococcal meningitis. The course of induction therapy is at least four weeks, and consolidation therapy for at least 6 weeks.

fluconazole

Intervention Type DRUG

Fluconazole (400-600 mg/d) for consolidation therapy for at least 6 weeks.

Interventions

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Amphotericin B Colloidal Dispersion

Amphotericin B Colloidal Dispersion 3.0-4.0 mg/kg/d (subject to adjustment, maximum dose not exceeding 6.0 mg/kg/d) . The course of induction therapy is at least four weeks.

Intervention Type DRUG

flucytosine

Flucytosine 100 mg/kg/d for induction therapy and consolidation therapy of cryptococcal meningitis. The course of induction therapy is at least four weeks, and consolidation therapy for at least 6 weeks.

Intervention Type DRUG

fluconazole

Fluconazole (400-600 mg/d) for consolidation therapy for at least 6 weeks.

Intervention Type DRUG

Other Intervention Names

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Amphotericin B Cholesteryl Sulfate Complex for Injection fluorocytosine Diflucan

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No