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临床试验/NCT03578133
NCT03578133已完成不适用

A Cross-sectional Study Investigating the Causes of Pneumonia in Two Community Clinics in Two Yangon Townships, Myanmar

Myanmar Oxford Clinical Research Unit1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年7月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
1
主要终点
Proportion of patients with a positive B.pseudomallei culture result

研究概览

简要总结

This study will evaluate a new point of care diagnostic test for the diagnosis of melioidosis pneumonia in patients attending outpatient clinics in Yangon, Myanmar

详细描述

Melioidosis is caused by Burkholderia pseudomallei, a Gram-negative saprophytic environmental bacterium that is an important emerging tropical infection. There are an estimated 165,000 cases and 89,000 deaths world-wide each year. Eighty-four percent of cases are in SE Asia where mortality is 40%; far exceeding most recognised neglected tropical diseases. Pneumonia, secondary to either inhalation of B.pseudomallei or to bacteraemic spread to the lung is the commonest presentation (51%). Annually the highest burden (75%) of infection occurs in the rainy season in (75% in Thailand). Up to 80% patients have at least one recognised risk factor for melioidosis including; diabetes, alcohol-dependence, glucocorticoid therapy, chronic obstructive pulmonary disease (COPD), chronic renal disease and cancer. COPD and diabetes mellitus are amongst the top ten causes of death in Myanmar (2018). Patients with HIV have not been shown to have greater risk of B. pseudomallei than immunocompetent patients.

Melioidosis was discovered in Myanmar in 1911 by British pathologist Alfred Whitmore and his assistant CS Krishnaswami. Yet since 1949 there have been few published cases. Under-reporting is partly due to difficulty in diagnosing melioidosis. Clinical and radiological findings are indistinguishable from tuberculosis. Laboratory diagnosis is challenging, lack of facilities, expertise and awareness of B.pseudomallei results in missed diagnostic opportunities.

Culture is the gold-standard diagnostic method but requires appropriate facilities and expertise which are not readily available in many developing countries like Myanmar. A rapid diagnostic (RDT) test has been developed for low resource settings that has been evaluated in Laos and India. The InBios® Active Melioidosis DetectTM-Lateral Flow Assay (AMD-LFA) detects B.pseudomallei 6-deoxyheptan capsular polysaccharide antigen. Shaw et al demonstrated sensitivity 85.71% (CI:74.61% to 93.25%) and specificity 93.62% (CI:88.23% to 97.04%), with positive predictive value of 85.71% (CI: 75.98% to 91.92%) compared to culture. We propose to evaluate this test for the diagnosis of melioidosis pneumonia in Myanmar.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

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

入选标准

  • >18 years old
  • Reported fever or axillary temperature > 37.5 °C
  • Productive cough
  • Written informed consent

排除标准

  • Inability to provide a sputum specimen

结局指标

主要结局

Proportion of patients with a positive B.pseudomallei culture result

时间窗: January 2019

Number of patients with a positive sputum culture for B.pseudomallei expressed as a proportion of all patients

1) Sensitivity, specificity, positive predictive value, negative predictive value of the RDT compared to culture

时间窗: January 2019

Using culture as the gold-standard the performance of the lateral flow assay will be assessed

次要结局

  • Proportion of patients diagnosed with Influenza A/B(March 2019)
  • Proportion of patients diagnosed with tuberculosis (TB) including multidrug resistant TB(January 2019)

研究者

发起方
Myanmar Oxford Clinical Research Unit
申办方类型
Other
责任方
Sponsor

研究点 (1)

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