Liposomal Amphotericin B for the Treatment of Cryptococcal Meningitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2016-12-31

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.

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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.

Conditions

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Cryptococcal Meningitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lipo-AB

Group Type EXPERIMENTAL

Liposomal amphotericin B

Intervention Type DRUG

4mg/kg/day, IV infusion

Amphotericin B

Group Type ACTIVE_COMPARATOR

Amphotericin B-deoxycholate

Intervention Type DRUG

1mg/kg/day, IV infusion

Interventions

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Liposomal amphotericin B

4mg/kg/day, IV infusion

Intervention Type DRUG

Amphotericin B-deoxycholate

1mg/kg/day, IV infusion

Intervention Type DRUG

Other Intervention Names

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Lipo-AB Amphotericin B

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No