Clinical trial NCT02136030: Liposomal Amphotericin B for the Treatment of Cryptococcal Meningitis
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cryptococcal Meningitis
Keywords: Cryptococcal meningitis
Lead sponsor: TTY Biopharm
Sponsor class: INDUSTRY
First posted: 2014-05-12
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: suscceful response rate
timeFrame: Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yee-chun Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perfect JR, Dismukes WE, Dromer F, Goldman DL, Graybill JR, Hamill RJ, Harrison TS, Larsen RA, Lortholary O, Nguyen MH, Pappas PG, Powderly WG, Singh N, Sobel JD, Sorrell TC. Clinical practice guidelines for the management of cryptococcal disease: 2010 update by the infectious diseases society of america. Clin Infect Dis. 2010 Feb 1;50(3):291-322. doi: 10.1086/649858.
citation: Adler-Moore JP, Gangneux JP, Pappas PG. Comparison between liposomal formulations of amphotericin B. Med Mycol. 2016 Mar;54(3):223-31. doi: 10.1093/mmy/myv111. Epub 2016 Jan 14.