Liposomal Amphotericin B for the Treatment of Cryptococcal Meningitis

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of liposomal amphotericin B and amphotericin B deoxycholate with or without flucytosine followed by fluconazole for the treatment of cryptococcal meningitis.

Detailed Description
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Subjects who meet all eligible requirements will be randomized into study group （Lipo-AB）or control group（Amphotericin B deoxycholate） in 2:1 ratio. Subjects will be treated with induction therapy in study group or in control group with flucytosine for at least 14 days, and followed by consolidation therapy for another 56 days after CSF sterilization.

Official Title
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A Randomized Study to Evaluate the Safety and Efficacy of Liposomal Amphotericin B and Amphotericin B Deoxycholate With or Without Flucytosine Followed by Fluconazole, for the Treatment of Cryptococcal Meningitis

Conditions
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Cryptococcal Meningitis

Intervention / Treatment
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* Drug: Liposomal amphotericin B
* Drug: Amphotericin B-deoxycholate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with age of at least 18 years. Within 7 days prior to, or at the time of screening visit, patient with cryptococcus meningitis, diagnosed by : CSF India ink staining positive OR CSF cryptococcal antigen test positive OR CSF culture positive Patient or his/her legally acceptable representative has signed the written informed consent form. Exclusion Criteria: Patients have laboratory abnormalities within 3 days prior to screening visit : ALT > 5x UNL, AST > 5x UNL, Creatinine > 2mg/dl Patient is pregnant or lactating. Patient participate other investigational drug trial within 1 month before entering this study. Patient has some indications that another systemic antifungal drug would be needed in addition to assigned drugs in study. Patient had contraindication of amphotericin B or azole. Patient is not available for lumbar puncture. Patient with life expectancy less than 5 days.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lipo-AB<br> | Drug: Liposomal amphotericin B<br>* 4mg/kg/day, IV infusion<br>* Other names: Lipo-AB;|
| Active Comparator: Amphotericin B<br> | Drug: Amphotericin B-deoxycholate<br>* 1mg/kg/day, IV infusion<br>* Other names: Amphotericin B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| suscceful response rate | Successful response was defined as both satisfactory clinical and microbiological response at the completion of 14 days treatment period. | Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cryptococcal meningitis