A Multicentre Observational Study to Describe the Prevalence of Scrub Typhus Defined as a Positive Rapid Diagnostic Test Among Selected Patients Presenting With Fever to Clinics in Myanmar
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Positive RDT Result
研究概览
简要总结
Fever is one of most common presenting complaints in clinics in tropical countries. Rickettsial infections, enteric fever and leptospirosis are common and important causes of undifferentiated fever in Southeast Asia. Scrub typhus is caused by Orientia tsutsugamushi and humans are typically infected by a bite of an infected chigger (trombiculid mite larva). Clinical diagnosis is unreliable for identifying scrub typhus, unless a tick eschar is present which is almost pathognomonic for the disease in Southeast Asia. A combination of culture, paired serology and PCR has been proposed as the gold-standard method for detection. As a result laboratory confirmation is not widely available and the diagnosis is missed frequently in clinical practice. Some progress has been made in developing such a test and one promising candidate is the Scrub Typhus Detect IgM Rapid Test (InBios International Inc). We plan to use to this test in this study to estimate the prevalence of scrub typhus in selected febrile patients presenting to clinics in Myanmar .
Patients will be followed up for one week to check for resolution of symptoms.
详细描述
Title: A multicenter observational study to describe the prevalence of scrub typhus defined as s positive rapid diagnostic test among selected patients presenting with fever to clinics in Myanmar.
Rational and objectives of the study Fever is one of most common presenting complaints in clinics in tropical countries. Rickettsial infections, enteric fever and leptospirosis are common and important causes of undifferentiated fever in Southeast Asia. The largest and earliest reports of scrub typhus in Myanmar were made during World War II when this disease afflicted numerous troops, particularly those serving close to the border with India. Scrub typhus is caused by Orientia tsutsugamushi and humans are typically infected by a bite of an infected chigger (trombiculid mite larva). Clinical diagnosis is unreliable for identifying scrub typhus, unless a tick eschar is present which is almost pathognomonic for the disease in Southeast Asia. A combination of culture, paired serology and PCR has been proposed as the gold-standard method for detection. As a result laboratory confirmation is not widely available and the diagnosis is missed frequently in clinical practice. Some progress has been made in developing such a test and one promising candidate is the Scrub Typhus Detect IgM Rapid Test (InBios International Inc). In laboratory-based evaluations using stored sera collected from patients recruited in a study in Thailand with confirmed scrub typhus this test had a sensitivity of ~80% for the detection of the disease compared to serological methods. We plan to use to this test in this study to estimate the prevalence of scrub typhus in selected febrile patients presenting to clinics in Myanmar.
Primary objective: To describe the prevalence of scrub typhus defined as a positive rapid diagnostic test among selected patients presenting with fever to clinics in Myanmar
Secondary objective:
- To assess inter-observer agreement when interpreting the tests
- To assess the ease-of-use of the tests
- To direct future research efforts into rickettsial disease in Myanmar
- To raise awareness of the presence of scrub typhus in Myanmar Inclusion criteria
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female >1 year of age
- •Fever defined as > 38 °C tympanic temperature
- •Duration of fever (self-reported) >48h
- •Written informed consent (by parent or legally acceptable representative in case of children), and assent for children aged 10-17 years
- •Eschar (60 patients only)
排除标准
- •Malaria confirmed by RDT or microscopy
- •Skin/soft tissue infection, dysentery or urinary tract infection probable cause of fever
结局指标
主要结局
Positive RDT Result
时间窗: 15 Minutes
Proportion of patients with a positive RDT result
次要结局
- Inter-observer agreement expressed as the kappa statistic(15 Minutes)
- Fever/symptom resolution(One Week)