NCT03988296已完成不适用
Adapting Novel Molecular Diagnostic Methods for Detection of Plasmodium Knowlesi in Sarawak, Malaysia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 3
- 主要终点
- Number of patients with a possible diagnosis of malaria
研究概览
简要总结
This study aims to determine the sensitivity, specificity, and practical value of two new molecular diagnostic assays compared to a more classical nested molecular diagnostic assay and the routine microscopy (both of which are the current gold standard) in detection of P. knowlesi.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected for malaria infection; fever (axillary or tympanic temperature ≥ 37.5 °C or oral or rectal temperature of ≥ 38 °C) with chills, worsening malaise, headache lassitude, fatigue, abdominal discomfort, muscle and joint aches, anorexia, perspiration, or vomiting at the time of evaluation or within the past 48 hours
- •Written informed consent is obtained.
- •For Children (>7 to <18 years): parent or legal guardian provides written informed consent.
排除标准
- •Patients living in, or returning from malaria endemic area outside of Sarawak within 2 weeks of illness onset
- •They have a clear alternative diagnosis other than malaria by a trained health care professional.
结局指标
主要结局
Number of patients with a possible diagnosis of malaria
时间窗: 10 weeks
Possible diagnosis of malaria as defined in accordance with the inclusion and exclusion criteria. Giemsa-stained thick and thin smears will be prepared for verification of parasitaemia by microscopy in the respective hospital laboratories
次要结局
- Statistical association between risk factors and diagnostic assays results.(10 weeks)
研究者
研究点 (3)
Loading locations...
相似试验
招募中
不适用
Comparison of novel assays for the molecular detection and quantification of bacteria in patients with bloodstream infections: COMBI studySepsisBacteraemia/ bacteremiaMolecular diagnosis bacteria in bloodNL-OMON21547VU University Medical Center80
已完成
不适用
Comparison of novel assays for the molecular detection and quantification of bacteria in patients with bloodstream infectionsbacteraemiabloodstream infectionsepsis (in case blood stream infection sepsis is regularly diagnosed)10004018NL-OMON39300Vrije Universiteit Medisch Centrum80
Enrolling By Invitation
不适用
New Molecular Approaches for Diagnosis of Prosthetic Joint InfectionProsthetic Joint InfectionNCT06670885I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio70
已完成
不适用
Diagnostics and Pharmacotherapy for Severe Forms of TB (DMID 15-0100)TuberculosisNCT03559582University of Virginia478
已完成
不适用
Conventional and Molecular Diagnostic Method for Patients With Suspected UTIUrinary Tract Infections-UTINCT02623179Southwest Regional PCR, LLC50