Clinical trial NCT05471063: Clinical Study of ABCD in the Treatment of Cryptococcal Meningitis
Official title: Clinical Study of Amphotericin B Colloidal Dispersion (ABCD) in the Treatment of Cryptococcal Meningitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cryptococcal Meningitis
Keywords: cryptococcal meningitis
Amphotericin B Colloidal Dispersion
non-HIV patients
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: CSPC Ouyi Pharmaceutical Group Co., Ltd.
First posted: 2022-07-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Proportion of patients with complete or partial response at the end of induction therapy
timeFrame: From enrollment to the end of induction therapy (about 4-6 weeks)
Secondary outcomes:
measure: Proportion of patients with complete or partial response at 4 weeks
timeFrame: At the 4 weeks of treatment
measure: Proportion of patients with complete or partial response at 10 weeks
timeFrame: At the 10 weeks of treatment
measure: Proportion of patients with complete or partial response at the end of consolidation therapy
timeFrame: At the end of the consolidation therapy (about 12 weeks)
measure: Cryptococcus antigen titer
timeFrame: 1,2,3,4,10 weeks
measure: Duration of the cryptococcal meningitis
timeFrame: At the end of the consolidation therapy (about 12 weeks)
measure: Adverse events
timeFrame: about 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Taisheng Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: