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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lipo-AB | Experimental |
| |
| Amphotericin B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal amphotericin B | Drug | 4mg/kg/day, IV infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| suscceful response rate | Successful response was defined as both satisfactory clinical and microbiological response at the completion of 14 days treatment period. | Day 14 |
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Inclusion Criteria:
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.
Exclusion Criteria:
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.
Patient is not available for lumbar puncture.
Patient with life expectancy less than 5 days.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yee-chun Chen, MD | Contact | 886-2-2312-3456 | 65054 | yeechunchen@gmail.com |
| Po-Liang Lu, MD | Contact | 886-7-3121101 | 5675 | d830166@cc.kmc.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Yee-chun Chen, MD | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | 100 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20047480 | Background | 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. | |
| 26768369 |
| Label | URL |
|---|---|
| Clinical trials network in Taiwan | View source |
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| ID | Term |
|---|---|
| D016919 | Meningitis, Cryptococcal |
| ID | Term |
|---|---|
| D016921 | Meningitis, Fungal |
| D020314 | Central Nervous System Fungal Infections |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C068538 | liposomal amphotericin B |
| C059765 | amphotericin B, deoxycholate drug combination |
| D000666 | Amphotericin B |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Amphotericin B-deoxycholate | Drug | 1mg/kg/day, IV infusion |
|
|
| Derived |
| 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. |
| D007239 | Infections |
| D003453 | Cryptococcosis |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |