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Liposomal Amphotericin B for the Treatment of Cryptococcal Meningitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02136030
Recruitment Status : Unknown
Verified October 2010 by TTY Biopharm.
Recruitment status was:  Recruiting
First Posted : May 12, 2014
Last Update Posted : May 12, 2014
Information provided by (Responsible Party):
TTY Biopharm

Tracking Information
First Submitted Date  ICMJE May 8, 2014
First Posted Date  ICMJE May 12, 2014
Last Update Posted Date May 12, 2014
Study Start Date  ICMJE February 2011
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
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 Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Liposomal Amphotericin B for the Treatment of Cryptococcal Meningitis
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cryptococcal Meningitis
Intervention  ICMJE
  • Drug: Liposomal amphotericin B
    4mg/kg/day, IV infusion
    Other Name: Lipo-AB
  • Drug: Amphotericin B-deoxycholate
    1mg/kg/day, IV infusion
    Other Name: Amphotericin B
Study Arms  ICMJE
  • Experimental: Lipo-AB
    Intervention: Drug: Liposomal amphotericin B
  • Active Comparator: Amphotericin B
    Intervention: Drug: Amphotericin B-deoxycholate
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 8, 2014)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02136030
Other Study ID Numbers  ICMJE TTYLA0701
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party TTY Biopharm
Study Sponsor  ICMJE TTY Biopharm
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yee-chun Chen, MD National Taiwan University Hospital
PRS Account TTY Biopharm
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP