Liposomal Amphotericin B for the Treatment of Cryptococcal Meningitis

Sponsor

TTY Biopharm (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02136030

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cryptococcal Meningitis	Drug: Liposomal amphotericin B Drug: Amphotericin B-deoxycholate	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lipo-AB	Drug: Liposomal amphotericin B 4mg/kg/day, IV infusion Other Names: Lipo-AB
Active Comparator: Amphotericin B	Drug: Amphotericin B-deoxycholate 1mg/kg/day, IV infusion Other Names: Amphotericin B

Arm

Intervention/Treatment

Experimental: Lipo-AB

Drug: Liposomal amphotericin B

4mg/kg/day, IV infusion

Other Names:

Lipo-AB

Active Comparator: Amphotericin B

Drug: Amphotericin B-deoxycholate

1mg/kg/day, IV infusion

Other Names:

Amphotericin B

Outcome Measures

Primary Outcome Measures

suscceful response rate [Day 14]
Successful response was defined as both satisfactory clinical and microbiological response at the completion of 14 days treatment period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.