Role of Detection of Lipoarabinomannan (LAM) in Urine for Diagnosis of Pulmonary Tuberculosis in HIV Patients; Egyptian Experience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 214
- 主要终点
- positive for TB
研究概览
简要总结
A diagnostic validity study in which urinary LAM was done in seropositive HIV patients with symptoms suggestive of TB who were included and investigated with battery of tests to reach the final diagnosis.
详细描述
A diagnostic validity study in which urinary LAM was done in seropositive HIV patients with symptoms suggestive of TB who were included and investigated with battery of tests to reach the final diagnosis.
The study was conducted at Mansoura Fever Hospital in collaboration with the Chest Department and Clinical Pathology Department, Mansoura University, Egypt, from January 2015 to October 2016.
Ethical approval had been obtained from Medical Research Ethics Committee of Faculty of Medicine, Mansoura University (code no: MD/138). Approval from Egyptian Ministry of Health was taken (No: 1-2016/18). Patients signed their written consents after detailed explanation of the study protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The study included seropositive HIV patients with a new diagnosis of either pulmonary or extra-pulmonary TB, and also included patients who were presented by symptoms suggestive for tuberculosis, changes in chest X ray that not improved by full course of antibiotics or positive tuberculin test ≥ 5 mm.
排除标准
- •Patients on anti-TB drugs or negative screening for sero-positive HIV patients were excluded from the study.
结局指标
主要结局
positive for TB
时间窗: day 1
Concentration of urinary LAM was done in seropositive HIV patients
次要结局
未报告次要终点
研究者
Assem Hewidy
assistant professor of chest medicine
Mansoura University