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临床试验/NCT04532463
NCT04532463已完成不适用

Clinical Effectiveness and Safety of Amphotericin B With Flucytosine-Fluconazole Therapy for Cryptococcal Meningitis in Patients With HIV Infection

University of Pharmacy, Yangon1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Clinical effectiveness

研究概览

简要总结

To study the clinical effectiveness and safety of amphotericin B with flucytosine-fluconazole therapy for cryptococcal meningitis in patients with HIV infection.

详细描述

Cryptococcal meningitis is an AIDS-defining illness mostly caused by the fungus, Cryptococcus neoformans. In high-income countries, the use of amphotericin B in combination with a more expensive drug, flucytosine, is most effective for the management of cryptococcal meningitis; but access to flucytosine is severely limited in middle and low-income countries. In Myanmar, currently recommended regimen for cryptococcal meningitis are combination of amphotericin B with fluconazole. Although amphotericin plus flucytosine followed by fluconazole therapy is the currently preferred regimen in WHO treatment guidelines, it is not still commonly used in Myanmar clinical practice because of its limited availability. Therefore, the data regarding tolerability and clinical effectiveness of flucytosine are unavailable for Myanmar patients.

Although trials were carried out for investigating the effectiveness of flucytosine in the HIV population of Africa, the variability in drug response can occur in Myanmar patients due to the racial and genetic differences and whether it is effective and safe for Myanmar people is a great curiosity question for clinicians and healthcare workers. In Myanmar, amphotericin plus flucytosine followed by fluconazole regimen will be supplied by National AIDS Program (NAP) and indicated in 2020. Thus, the documents for effectiveness and safety profile need to be established. This is the reason that the effectiveness and safety of amphotericin B with flucytosine and fluconazole combination therapy should be studied. From this study, it can provide information to physicians regarding the effectiveness as well as safety of those drugs in the management of cryptococcal meningitis in HIV patients.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with HIV-associated cryptococcal meningitis, admitted to inpatient department of SHW, SHM, SHT, YGH, NOGTH and IGH during the study period
  • Patients of both sexes
  • Age above 14 years
  • Patients or caregivers who will give informed consent to participate in this study

排除标准

  • 未提供

研究组 & 干预措施

Amphotericin B,Flucytosine, Fluconazole

Amphotericin B 1 mg/kg 1 week & Flucytosine 100 mg/kg 1 week followed by Fluconazole 1200 mg/day 1 week

干预措施: Amphotericin B 1 mg/kg 1 week & Flucytosine 100 mg/kg 1 week followed by Fluconazole 1200 mg/day 1 week (Drug)

结局指标

主要结局

Clinical effectiveness

时间窗: 14 days (day1 to day 14)

1. To describe the clinical effectiveness of amphotericin B with flucytosine-fluconazole combination therapy by assessing clinical parameters (presence of headache, fever, convulsion, abnormal mental status and death) at day 1, day 7 and day 14 2. To determine the severity of headache before and after treatment by numerical rating scale

Clinical safety

时间窗: 14 days (day1 to day 14)

3. . To describe the clinical safety of amphotericin B with flucytosine-fluconazole combination therapy by assessing hematological and biochemical parameters (hemoglobin, neutrophil, platelet, ALT, AST, serum creatinine and serum potassium level ) by DAIDS grading at baseline, day 7 and day 14

次要结局

  • back-ground characteristics of patients(14 days (day1 to day 14))

研究者

发起方
University of Pharmacy, Yangon
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ms. Zin Win May, Principal Investigator

Clinical effectiveness and safety of Amphotericin B with Flucytosine-Fluconazole therapy for Cryptococcal meningitis in patients with HIV infection

University of Pharmacy, Yangon

研究点 (1)

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