Clinical Trial: Liposomal Amphotericin B for the Treatment of Cryptococcal Meningitis

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

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 Cryptococca

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 Summary: 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.
Sponsor: TTY Biopharm

Current Primary Outcome: suscceful response rate [ Time Frame: Day 14 ]

Successful response was defined as both satisfactory clinical and microbiological response at the completion of 14 days treatment period.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: TTY Biopharm

Dates:
Date Received: May 8, 2014
Date Started: February 2011
Date Completion: December 2016
Last Updated: May 8, 2014
Last Verified: October 2010