Cryptococcal MeningitisNCT02136030
Liposomal Amphotericin B for the Treatment of Cryptococcal Meningitis
A study testing Liposomal amphotericin B and Amphotericin B-deoxycholate in people with Cryptococcal Meningitis, run by TTY Biopharm at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cryptococcal Meningitis
- What is being tested?
- Liposomal amphotericin B and Amphotericin B-deoxycholate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2011to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
About this study
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
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.
Read the 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.
- Conditions
- Cryptococcal Meningitis
- Being tested
- Liposomal amphotericin B, Amphotericin B-deoxycholate
- Keywords
- Cryptococcal meningitis
- Medical subject headings
- Meningitis, Cryptococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal amphotericin BDrug
Also called Lipo-AB
4mg/kg/day, IV infusion
Amphotericin B-deoxycholateDrug
Also called Amphotericin B
1mg/kg/day, IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Lipo-AB | Experimental | Not described Receives: Drug: Liposomal amphotericin B |
| Amphotericin B | Active comparator | Not described Receives: Drug: Amphotericin B-deoxycholate |
What is being measured
The primary outcome is the main question the study is designed to answer.
suscceful response rate
Successful response was defined as both satisfactory clinical and microbiological response at the completion of 14 days treatment period.
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startFeb 2011
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cryptococcal MeningitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TTY Biopharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yee-chun Chen, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136030
- Sponsor's protocol ID
- TTYLA0701
- Status last verified
- Oct 2010
- First submitted
- 8 May 2014
- Last updated
- 12 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20047480Adler-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.
PubMed 26768369
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02136030
- Acronym / sponsor ID
- TTYLA0701
- Conditions
- Cryptococcal Meningitis
- Keywords
- Cryptococcal meningitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- TTY BiopharmIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 12 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lipo-AB | Experimental | Drug: Liposomal amphotericin B |
| Amphotericin B | Active comparator | Drug: Amphotericin B-deoxycholate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 :
- Patient or his/her legally acceptable representative has signed the written informed consent form.
Key exclusion criteria (10 listed)
- Patients have laboratory abnormalities within 3 days prior to screening visit :
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal amphotericin BAlso: Lipo-AB4mg/kg/day, IV infusion | Drug | Lipo-AB |
| Amphotericin B-deoxycholateAlso: Amphotericin B1mg/kg/day, IV infusion | Drug | Amphotericin B |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2014.
- Background: PubMed 20047480Perfect 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.
- Derived from this study: PubMed 26768369Adler-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.
- Clinical trials network in TaiwanLink provided by the sponsor.
Related trials for Cryptococcal Meningitis
RecruitingObservational study
Fungal Infection Susceptibility
Cryptococcal Infection, Cryptococcal Pneumonia
RecruitingObservational study
Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia
Idiopathic CD4+ Lymphocytopenia, Cryptococcal Meningitis
Not yet recruitingPhase 3
Optimizing Care for Cryptococcal Antigenemia: Evaluation of Short Course Fluconazole and ART Timing Among CrAg+ Persons With Low Titers
Cryptococcal Antigenemia, HIV-1-infection
RecruitingPhase 2/3
Platform Trial For Cryptococcal Meningitis (PLATFORM-CM)
Hiv, Cryptococcal Meningitis
RecruitingPhase 2/3
Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia
Cryptococcal Meningitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yee-chun Chen, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liposomal amphotericin B and Amphotericin B-deoxycholate in people with Cryptococcal Meningitis, run by TTY Biopharm at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yee-chun Chen, MD (886-2-2312-3456 ext. 65054, yeechunchen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
suscceful response rate (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02136030, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2014.