Human Immunodeficiency Virus Negative Host Talaromyces Between Voriconazole and Amphotericin B Sequential Itraconazole Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of Participants with all-cause mortality
研究概览
简要总结
Through a multi-center large-sample non-randomized controlled study, the effect of voriconazole, amphotericin B sequential itraconazole therapy on Talaromyces in Human Immunodeficiency Virus（HIV）negative hosts were compared to clarify whether the two therapies were equivalent; A comprehensive efficacy evaluation system and standard treatment program was established to provide a basis for standardized treatment of Talaromyces in Human Immunodeficiency Virus negative hosts.The observational indicators included: 2-week all-cause mortality; 24-week all-cause mortality; clinical improvement time; level of decrease of fungus in the blood culture medium two weeks before treatment; recurrence; appearance of adverse drug reaction at the level 3 and above. Dynamically monitor the immune cells and factors like anti-Interferon-γ autoantibodies, Interferon-γ, Th1/Th2, and Th17/Treg in the HIV-negative Talaromyces host microenvironment, and observe the host's immune status and its change. 3. study the effect of absence of Interferon-γ and Interferon-γ Receptor (IFN-γR）on the activation and function of anti-Interferon-γ autoantibodies, Th1/Th2, and Th17/Treg by establishing a Talaromyces mouse model that knocks out the Interferon-γ and IFN-γR gene and a IFN-γ silenced cell model; Study the effect of anti-IFN-γ autoantibody on the activation and function of IFN-γ、Th1/Th2、Th17/Treg by increasing its titer in vitro and vivo; determine by which path the anti-IFN-γ autoantibody of HIV-negative host influences its immune regulation mechanism; finally, the intervention effect of IFN-γ on high titer anti-IFN-γ autoantibodies is studied, providing a new idea for immunotargeted therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-negative adults (≥18 years of age) who diagnosis of talaromyces that was confirmed by either microscopy or culture
- •Must be able to swallow tablets
排除标准
- •Pregnancy, central nervous system involvement assessed either clinically or by analyses of cerebrospinal fluid
- •An allergy to voriconazole, itraconazole or amphotericin
- •The concomitant use of certain medications that interact with voriconazole, itraconazole or amphotericin
- •An alanine aminotransferase or aspartate aminotransferase level of more than 400 U per liter
- •An absolute neutrophil count of less than 500 per cubic millimeter
- •A creatinine clearance of less than 30 ml per minute (calculated by the method of Cockcroft and Gault)
- •a concurrent diagnosis of cryptococcal meningitis
- •concurrent treatment with rifampicin
- •previous treatment for talaromyces for more than 48 hours
- •HIV positive who diagnosis of talaromyces.
研究组 & 干预措施
HIV Negative Host talaromyces using Voriconazole
Voriconazole On the first day, 6 mg/kg bid was given, and then 4 mg/kg bid was given intravenously for 6 days, and then oral voriconazole 200 mg bid was administered to maintain treatment for at least 6 months.
干预措施: Voriconazole (Drug)
HIV Negative talaromyces AMB Sequential Itraconazole
Amphotericin B (AMB) sequential itraconazole group (intravenous amphotericin, dose 0.7 - 1.0 mg / kg / d, 14 days, then changed oral itraconazole 200 mg bid for 10 weeks, after which 100 mg bid maintenance Until cluster of differentiation 4 (CD4+ T) cells are greater than 100 cells/L for at least 6 months
干预措施: Voriconazole (Drug)
结局指标
主要结局
Number of Participants with all-cause mortality
时间窗: up to 24 weeks
defined as the absolute risk of death from any cause during 24 weeks
Number of Participants with Clinical resolution of talaromyces
时间窗: 3 days
Clinical resolution of talaromyces was defined as a temperature of less than 38°C (100°F) for 3 days, resolution of skin lesions, and tertile blood cultures. Early fungicidal activity was defined as the rate of decline in blood T. marneffei colony forming units (CFUs).
Number of Participants with Early fungicidal activity
时间窗: up to 2 weeks
defined as the rate of decline in blood T. marneffei CFUs from sterical blood cultures obtained during the first 2 weeks.
Number of Participants with Relapse of talaromyces
时间窗: an average of 1 year
defined as the recurrence of symptoms and a positive fungal culture from any sterile site that led to reinduction of therapy in patients who had achieved clinical resolution.
次要结局
未报告次要终点
研究者
Qiu Ye
Clinical Professor
Guangxi Medical University