Liposomal Amphotericin B for the Treatment of Cryptococcal Meningitis

May 8, 2014 updated by: TTY Biopharm

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lipo-AB
Drug: Liposomal amphotericin B
4mg/kg/day, IV infusion
Other Names:
  • Lipo-AB
Active Comparator: Amphotericin B
Drug: Amphotericin B-deoxycholate
1mg/kg/day, IV infusion
Other Names:
  • Amphotericin B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TTY Biopharm

Investigators

  • Principal Investigator: Yee-chun Chen, MD, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

May 8, 2014

First Submitted That Met QC Criteria

May 8, 2014

First Posted (Estimate)

May 12, 2014

Study Record Updates

Last Update Posted (Estimate)

May 12, 2014

Last Update Submitted That Met QC Criteria

May 8, 2014

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TTYLA0701

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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