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 range
18 Years – 70 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)