Clinical Study of ABCD in the Treatment of Cryptococcal Meningitis (NCT05471063) | Clinical Trial Compass
UnknownNot Applicable
Clinical Study of ABCD in the Treatment of Cryptococcal Meningitis
China30 participantsStarted 2022-08-22
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 la…
What they're measuring
1
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)