Clinical Outcomes of Cryptococcal Meningitis Among HIV-infected Patients in the Era of Antiretroviral Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Long-term survival rate of CM
研究概览
简要总结
Cryptococcal meningitis is one of the most common central nervous system infections among HIV-infected patients. The outcome is generally severe. This study aims to determine long-term survival rate among HIV-infected CM patients in the era of antiretroviral therapy (ART). The secondary objectives are to clarify outcomes of CM and determine prognostic factors.
详细描述
Study site:
The study are conducted at the Division of Infectious Diseases, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
Sample size calculation:
The sample size is obtained by using EPI Info program. Anticipated population proportion P which will be the major outcome of CM, the survival rate was 63% in Thailand (Chottanapund S, Singhasivanon P, Kaewkungwal J, Chamroonswasdi K, Manosuthi W. Survival time of HIV-infected patients with cryptococcal meningitis. J Med Assoc Thai. 2007 Oct;90(10):2104-11. PubMed PMID: 18041430). At the effect size of 80%, confidence level at 95% (P = 0.05), deviation error of allowanced of 5% and 210 expects HIV infected patients with CM during study period at Ramathibodi Hospital, the estimated sample size is 132 cases.
Outcome measurement:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-infected patients diagnosed by positive results of 2 different ELISA tests, 1 ELISA test accompanied with 1 HIV-PCR test, or 1 ELISA test accompanied with 1 Western blot test, whose age was more than 15 years old.
- •Newly diagnosed CM during the study period defined by positive culture, positive Indian ink or positive latex agglutination test on CSF with typical symptoms at Ramathibodi Hospital.
排除标准
- •Patients who had other known CNS co-infection or other significant concurrent CNS diseases which might influence on outcome of CM.
结局指标
主要结局
Long-term survival rate of CM
时间窗: Up to 12 years. Cases will be censored at the date of last visit if they are lost to follow up or referred to another hospital, and will be censored at the date of death.
To describe long-term survival rate of CM among adult HIV-infected patients in the era of ART.
次要结局
- Risk factors of short-term and long-term mortality of CM(Up to 12 years. Cases will be censored at the date of last visit if they are lost to follow up or referred to another hospital, and will be censored at the date of death.)
研究者
Punnee Pitisuttithum
Prof.
Mahidol University