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Liposomal Amphotericin B for the Treatment of Cryptococcal Meningitis

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
TTY Biopharm

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.

Condition or disease Intervention/treatment Phase
Cryptococcal Meningitis Drug: Liposomal amphotericin B Drug: Amphotericin B-deoxycholate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2011
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016


Arm Intervention/treatment
Experimental: Lipo-AB Drug: Liposomal amphotericin B
4mg/kg/day, IV infusion
Other Name: Lipo-AB

Active Comparator: Amphotericin B Drug: Amphotericin B-deoxycholate
1mg/kg/day, IV infusion
Other Name: Amphotericin B




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02136030


Contacts
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Contact: Yee-chun Chen, MD 886-2-2312-3456 ext 65054 yeechunchen@gmail.com
Contact: Po-Liang Lu, MD 886-7-3121101 ext 5675 d830166@cc.kmc.edu.tw

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Sponsors and Collaborators
TTY Biopharm
Investigators
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Principal Investigator: Yee-chun Chen, MD National Taiwan University Hospital

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: TTY Biopharm
ClinicalTrials.gov Identifier: NCT02136030     History of Changes
Other Study ID Numbers: TTYLA0701
First Posted: May 12, 2014    Key Record Dates
Last Update Posted: May 12, 2014
Last Verified: October 2010

Keywords provided by TTY Biopharm:
Cryptococcal meningitis

Additional relevant MeSH terms:
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Meningitis
Meningitis, Cryptococcal
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Fungal
Central Nervous System Fungal Infections
Mycoses
Cryptococcosis
Central Nervous System Infections
Amphotericin B
Liposomal amphotericin B
Amphotericin B, deoxycholate drug combination
Deoxycholic Acid
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents
Cholagogues and Choleretics
Gastrointestinal Agents