Epidemiology of Malaria in Ubon Ratchathani, Thailand: a Case-control Study
试验速览
- 阶段
- 不适用
- 入组人数
- 660
- 试验地点
- 1
- 主要终点
- Risk factors for Malaria infection
研究概览
简要总结
This is an observational study (case-control study) aiming to identify risk factors for malaria infection in health centers or malaria posts or district hospitals in Buntharik District and Nachalui District, Ubon Ratchathani Province, Thailand.
This study expects to recruit 330 cases (malaria positive) and 330 control (negative cases) subject. One-to-one matching of cases (malaria positive) and controls (malaria negative) will be done at each study site.
CASE (Malaria positive) subject will go through the following;
- Enrollment visit (Day 0)
1.1 Blood collection of three dried blood spots, and malaria slide. In district hospitals in individuals >14 kg: additional 10ml venous blood will be collected.
1.2 A survey questionnaire which includes patient demographics, information on malaria treatment, bed net use and possible risk factors for acquiring malaria, as well as questions about their travel and usage of mobile phones will be administered. 2. Follow up visits (if fever plus Day 42 (+/-3))
2.1 Blood collection of three dried blood spots and malaria slide. In district hospitals: additional 0.5ml venous blood will be collected.
2.2 Short survey questionnaire including questions on symptoms, travel and possible risk behaviors since enrollment will be administered.
CONTROL (Malaria negative) subject will go through the following;
- Enrollment visit (Day 0)
1.1 Blood collection to confirm negative malaria slide. In district hospitals: additional 0.5ml venous blood will be collected.
1.2 A survey questionnaire including patient demographics, information on any recent malaria treatment they may have taken, bed net use and possible risk factors for acquiring malaria, as well as questions about their travel and usage of mobile phones will be administered. 2. Follow up visit: No follow up visit
详细描述
Study sites and enrollment:
Patients self-presenting to (1) health centres or(2) malaria posts or (3) district hospitals in Buntharik District and Nachalui District, Ubon Ratchathani Province, Thailand and requiring a diagnostic test for malaria as determined by the treating clinician will be recruited. Those who are malaria positive will be candidate cases and those who are malaria negative will be candidate controls.
One-to-one matching of cases and controls will be done at each study site. One control will be matched to each case. The matching criteria will be the next malaria negative patient to attend the study site of the same gender and age+/-5 years as an enrolled malaria positive case.
Study procedure:
CASE (Malaria patient defined by positive RDT or blood smear)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Case (Malaria patient defined by positive RDT or blood smear):
- •Patients of ≥ 6 months of age testing positive for malaria of any species as determined by a positive rapid diagnostic test (RDT) or asexual stage parasites on a smear of peripheral blood including individuals with more than one species of Plasmodium.
- •Control (Non-malaria patient defined by negative RDT or blood smear):
- •Patients > 6 months of age requiring a diagnostic test for malaria but testing negative for malaria by rapid diagnostic test (RDT) or asexual stage parasites on a smear of peripheral blood. Controls will be age and gender matched to individual cases at each study site (details below).
排除标准
- •Not willing to provide written informed consent.
结局指标
主要结局
Risk factors for Malaria infection
时间窗: 2 years
Risk factors for malaria infection in Ubon Ratchathani Province, Thailand
次要结局
- Human movement leading to spread of malaria and antimalarial drug resistance(2 years)
- Measure antimalarial drug in blood prior to participate in the study(2 years)
- Proportion of malaria infections in Ubon Ratchathani Province(2 years)
- Prevalence of clinical antimalarial drug resistance(2 years)