NCT02136030

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 12, 2014

Status Verified

October 1, 2010

Enrollment Period

4.8 years

First QC Date

May 8, 2014

Last Update Submit

May 8, 2014

Conditions

Cryptococcal Meningitis

Keywords

Cryptococcal meningitis

Outcome Measures

Primary Outcomes (1)

  • suscceful response rate

    Successful response was defined as both satisfactory clinical and microbiological response at the completion of 14 days treatment period.

    Day 14

Study Arms (2)

Lipo-AB

EXPERIMENTAL
Drug: Liposomal amphotericin B

Amphotericin B

ACTIVE COMPARATOR
Drug: Amphotericin B-deoxycholate

Interventions

Liposomal amphotericin BDRUG

4mg/kg/day, IV infusion

Also known as: Lipo-AB
Lipo-AB
Amphotericin B-deoxycholateDRUG

1mg/kg/day, IV infusion

Also known as: Amphotericin B
Amphotericin B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with age of at least 18 years.
  • Within 7 days prior to, or at the time of screening visit, patient with cryptococcus meningitis, diagnosed by :
  • CSF India ink staining positive OR
  • CSF cryptococcal antigen test positive OR
  • CSF culture positive
  • Patient or his/her legally acceptable representative has signed the written informed consent form.

You may not qualify if:

  • Patients have laboratory abnormalities within 3 days prior to screening visit :
  • ALT \> 5x UNL,
  • AST \> 5x UNL,
  • Creatinine \> 2mg/dl
  • Patient is pregnant or lactating.
  • Patient participate other investigational drug trial within 1 month before entering this study.
  • Patient has some indications that another systemic antifungal drug would be needed in addition to assigned drugs in study.
  • Patient had contraindication of amphotericin B or azole.
  • Patient is not available for lumbar puncture.
  • Patient with life expectancy less than 5 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (2)

  • 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.

    PMID: 20047480BACKGROUND

  • Adler-Moore JP, Gangneux JP, Pappas PG. Comparison between liposomal formulations of amphotericin B. Med Mycol. 2016 Mar;54(3):223-31. doi: 10.1093/mmy/myv111. Epub 2016 Jan 14.

    PMID: 26768369DERIVED

Related Links

MeSH Terms

Conditions

Meningitis, Cryptococcal

Interventions

liposomal amphotericin Bamphotericin B, deoxycholate drug combinationAmphotericin B

Condition Hierarchy (Ancestors)

Meningitis, FungalCentral Nervous System Fungal InfectionsMycosesBacterial Infections and MycosesInfectionsCryptococcosisCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System DiseasesMeningitisNeuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Yee-chun Chen, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yee-chun Chen, MD

CONTACT

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

Po-Liang Lu, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2014

First Posted

May 12, 2014

Study Start

February 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

May 12, 2014

Record last verified: 2010-10

Locations

TW(1)