Loading clinical trials...

UNKNOWNNA

Liposomal Amphotericin B for the Treatment of Cryptococcal Meningitis

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

NCT02136030•TTY Biopharm

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan

Key Dates

Start Date

February 1, 2011

Primary Completion Date

December 1, 2015

Completion Date

December 1, 2016

Last Updated

May 12, 2014

Enrollment

ESTIMATED participants

Conditions

Cryptococcal Meningitis

Interventions

Liposomal amphotericin B

DRUG

Amphotericin B-deoxycholate

DRUG

Contacts

Yee-chun Chen, MD

CONTACT

886-2-2312-3456 yeechunchen@gmail.com

Po-Liang Lu, MD

CONTACT

886-7-3121101 d830166@cc.kmc.edu.tw

Point of Care Tests to Identify Opportunistic Infections in Advanced HIV Patients in Mexico City

NCT05685641

Acquired Immunodeficiency SyndromeHistoplasmosis AIDS+2 more

View study

COMPLETEDPHASE3

Adjunctive Sertraline for the Treatment of HIV-Associated Cryptococcal Meningitis

NCT01802385

Cryptococcal MeningitisFungal Meningitis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 12, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Liposomal Amphotericin B for the Treatment of Cryptococcal Meningitis

Inclusion Criteria

Exclusion Criteria

Point of Care Tests to Identify Opportunistic Infections in Advanced HIV Patients in Mexico City

Adjunctive Sertraline for the Treatment of HIV-Associated Cryptococcal Meningitis

Operational Research for Cryptococcal Antigen Screening

CryptoART Study: Decreasing Mortality Associated With Initiation of Antiretroviral Therapy in Sub-Saharan Africa

Vietnam Cryptococcal Retention in Care Study (CRICS) Federal Financial Report