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临床试验/NCT03819348
NCT03819348Unknown不适用

The First Affiliated Hospital of Guangxi Medical University

Guangxi Medical University1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2003年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,200
试验地点
1
主要终点
clinical remission rate

研究概览

简要总结

Through a multi-center large-sample retrospective study, the epidemiological changes of TSM in Guangxi have been reviewed, its incidence trend was understood to attract the attention of clinicians; the multiple programs of antifungal therapy for HIV-negative host TSM were compared in terms of effect on clinical remission rate, effective rate, recurrence rate, mortality and toxic side effects on HIV-negative host TSM; their prognosis and recurrence indicators were clarified, and a therapeutic effect evaluation system was established, providing a standard treatment and diagnosis scheme for clinical practice; and simultaneously the positive rate of G and GM experiments in respect of TSM, Aspergillus and other fungi was identified to provide TSM with biological diagnostic indicators. Improve the level of understanding and diagnosis and treatment of HIV-negative TSM in the whole area. A comprehensive efficacy evaluation system and standard treatment program was established to provide a basis for standardized treatment of TSM in HIV-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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Eligible patients were HIV-negative adults who had talaromycosis that was confirmed by either microscopy or culture.

排除标准

  • patients were HIV-infected adults who had talaromycosis that was confirmed by either microscopy or culture.

结局指标

主要结局

clinical remission rate

时间窗: 7 days

Clinical resolution of talaromycosis was defined as a temperature of less than 38°C (100°F) for 3 days, resolution of skin lesions, and sterile blood cultures.

recurrence rate

时间窗: 12 months

Relapse of talaromycosis was 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.

mortality at 4 week

时间窗: 4 weeks

all-cause mortality was defined as the absolute risk of death from any cause during the first 2 weeks after randomization.

toxic side effects

时间窗: 24 weeks

Side effects were monitored clinically and with the use of hematologic, chemical, and liver-enzyme testing performed at least twice weekly

mortality at week 24

时间窗: 24 weeks

The secondary outcome measures were mortality at week 24, the time to clinical resolution of talaromycosis, early fungicidal activity, relapse of talaromycosis, and the incidence of adverse events of grade 3 or higher.

次要结局

  • G test(3 days)
  • GM test(3 days)

研究者

发起方
Guangxi Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Qiu Ye

Professor

Guangxi Medical University

研究点 (1)

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