Back to resultsLiposomal Amphotericin B for the Treatment of Cryptococcal Meningitis
Primary Purpose
Cryptococcal Meningitis
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Liposomal amphotericin B
Amphotericin B-deoxycholate
Sponsored by
About this trial
This is an interventional treatment trial for Cryptococcal Meningitis focused on measuring Cryptococcal meningitis
Eligibility Criteria
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.
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lipo-AB
Amphotericin B
Arm Description
Outcomes
Primary Outcome Measures
suscceful response rate
Successful response was defined as both satisfactory clinical and microbiological response at the completion of 14 days treatment period.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02136030
Brief Title
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
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TTY Biopharm
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cryptococcal Meningitis
Keywords
Cryptococcal meningitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lipo-AB
Arm Type
Experimental
Arm Title
Amphotericin B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Liposomal amphotericin B
Other Intervention Name(s)
Lipo-AB
Intervention Description
4mg/kg/day, IV infusion
Intervention Type
Drug
Intervention Name(s)
Amphotericin B-deoxycholate
Other Intervention Name(s)
Amphotericin B
Intervention Description
1mg/kg/day, IV infusion
Primary Outcome Measure Information:
Title
suscceful response rate
Description
Successful response was defined as both satisfactory clinical and microbiological response at the completion of 14 days treatment period.
Time Frame
Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yee-chun Chen, MD
Phone
886-2-2312-3456
Ext
65054
Email
yeechunchen@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Po-Liang Lu, MD
Phone
886-7-3121101
Ext
5675
Email
d830166@cc.kmc.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yee-chun Chen, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
20047480
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.
Results Reference
background
PubMed Identifier
26768369
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.
Results Reference
derived
Links:
URL
http://www.google.com/search?q=emome&ie=utf-8&oe=utf-8
Description
Clinical trials network in Taiwan
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Liposomal Amphotericin B for the Treatment of Cryptococcal Meningitis
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