NCT02136030

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: TTY Biopharm · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cryptococcal Meningitis

Interventions

Type	Name	Description
DRUG	Liposomal amphotericin B	4mg/kg/day, IV infusion
DRUG	Amphotericin B-deoxycholate	1mg/kg/day, IV infusion

Timeline

• Start date: 2011-02-01
• Primary completion: 2015-12-01
• Completion: 2016-12-01
• First posted: 2014-05-12
• Last updated: 2014-05-12

Locations

1 site across 1 country: Taiwan