Liposomal Amphotericin B for the Treatment of Cryptococcal Meningitis

Cryptococcal Meningitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02136030
• Other study ID #: TTYLA0701
• Status: Recruiting
• Phase: N/A
• First received: May 8, 2014
• Last updated: May 8, 2014
• Start date: February 2011
• Est. completion date: December 2016

Study information

• Verified date: October 2010
• Source: TTY Biopharm
• Contact: Yee-chun Chen, MD
• Phone: 886-2-2312-3456
• Email: yeechunchen[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cryptococcal Meningitis
• Meningitis
• Meningitis, Cryptococcal

Intervention

Drug:
• Liposomal amphotericin B
4mg/kg/day, IV infusion
• Amphotericin B-deoxycholate
1mg/kg/day, IV infusion

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
TTY Biopharm

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	suscceful response rate	Successful response was defined as both satisfactory clinical and microbiological response at the completion of 14 days treatment period.	Day 14	No

External Links

•   Clinical trials network in Taiwan