Status:
ENROLLING_BY_INVITATION
Amphotericin B for Non-HIV Cryptococcal Meningitis Patients
Lead Sponsor:
Huashan Hospital
Conditions:
Cryptococcal Meningitis
Antifungal Agents
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Cryptococcus neoformans and C. gatti are important causes of central nervous system (CNS) infections with significant mortality, remaining a great public health challenge worldwide. Commonly seen as a...
Eligibility Criteria
Inclusion
- Age more than 18 years
- HIV antibody negative
- Cryptococcal meningitis defined as a syndrome consistent with CM and one or more of: 1) positive CSF India ink (budding encapsulated yeasts), 2) C.neoformans cultured from CSF or blood, 3) positive cryptococcal antigen Lateral Flow Antigen Test (LFA) in CSF, 4) positive brain tissue representing Cryptococcus
- Having no severe immunocompromised conditions
- Informed consent to participate given by patient or acceptable representative
Exclusion
- Previously cryptococcal disease
- Currently receiving treatment for cryptococcal meningitis and having received ≥72 hours of anti-cryptococcal meningitis therapy in 96 hours
- Creatinine clearance lower than 80 ml/min
- Liver dysfunction (defined as ALT or AST \> 2×ULN and bilirubin \> 1.5×ULN, or ALT or AST \> 3×ULN, or bilirubin \> 2×ULN)
- Liver cirrhosis or chronic liver failure
- Pregnancy or breast-feeding
- Known allergy to study drugs
- Failure to consent - the patient, or if they are incapacitated, their responsible relative, declines to enter the study
Key Trial Info
Start Date :
August 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06178627
Start Date
August 13 2023
End Date
August 31 2026
Last Update
December 21 2023
Active Locations (2)
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1
Huashan Hospital
Shanghai, Shanghai Municipality, China, 200040
2
The Fourth People's Hospital of Nanning
Nanning, China, 530000