Liposomal Amphotericin B for the Treatment of Cryptococcal Meningitis

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02136030

Enrollment

Registered

2014-05-12

Start date

2011-02-28

Completion date

2016-12-31

Last updated

2014-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cryptococcal Meningitis

Keywords

Cryptococcal meningitis

Brief summary

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

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.

Interventions

DRUGLiposomal amphotericin B

4mg/kg/day, IV infusion

DRUGAmphotericin B-deoxycholate

1mg/kg/day, IV infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Adults with age of at least 18 years. 2. Within 7 days prior to, or at the time of screening visit, patient with cryptococcus meningitis, diagnosed by : 1. CSF India ink staining positive OR 2. CSF cryptococcal antigen test positive OR 3. CSF culture positive 3. Patient or his/her legally acceptable representative has signed the written informed consent form.

Exclusion criteria

1. Patients have laboratory abnormalities within 3 days prior to screening visit : 1. ALT \> 5x UNL, 2. AST \> 5x UNL, 3. Creatinine \> 2mg/dl 2. Patient is pregnant or lactating. 3. Patient participate other investigational drug trial within 1 month before entering this study. 4. Patient has some indications that another systemic antifungal drug would be needed in addition to assigned drugs in study. 5. Patient had contraindication of amphotericin B or azole. 6. Patient is not available for lumbar puncture. 7. Patient with life expectancy less than 5 days.

Design outcomes

Primary

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

Countries

Taiwan

Contacts

Primary ContactYee-chun Chen, MD

yeechunchen@gmail.com886-2-2312-3456

Backup ContactPo-Liang Lu, MD

d830166@cc.kmc.edu.tw886-7-3121101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026