G6PD Deficiency Prevalence and Targeted Elimination of Residual Plasmodium Vivax Hypnozoites in Community: Township Level Implementation in Banmauk and Moe Mauk, Myanmar
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,208
- 试验地点
- 1
- 主要终点
- Infection prevalence at 3-month intervals estimated through cross-sectional surveys
研究概览
简要总结
Plasmodium vivax has become the predominant species in the Greater Mekong Subregion and is a major challenge for regional malaria elimination. Mass primaquine administration has played a decisive role in malaria elimination in many temperate zone countries, but its efficacy in tropical areas remains to be evaluated. This study aims to assess the efficacy of targeted primaquine mass treatment (TPT) for eliminating P. vivax malaria in northern Myanmar.
详细描述
This study employed a cluster-randomized crossover design in which two groups of villages received TPT at different times. In August-September 2019, Group 1 received TPT (0.25 mg/kg/day primaquine base for 14 days), while Group 2 was the control. In June-July 2020, Group 2 received TPT, while Group 1 served as the control. To evaluate the effectiveness of TPT for preventing relapses of vivax malaria, two indicators were utilized: infection prevalence at 3-month intervals estimated through cross-sectional surveys and monthly malaria incidence by passive case detection. The data were analyzed using descriptive statistics, chi-squared test, cumulative hazard function, and mixed model logistic regression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- 是
入选标准
- •Residents in study villages
- •Male/ female
- •Consent to participate
排除标准
- •G6PD deficiency
- •pregnant women,
- •breastfeeding mothers and
- •children under 7 years
研究组 & 干预措施
TPT Group
Based on the WHO malaria treatment guidelines, a standard PQ regimen of 0.25 mg PQ base/kg body weight daily for 14 days was administered to eligible individuals through directly observed treatment (DOT) to ensure drug intake and monitor potential adverse effects during August-September 2019. The safety of each participant was monitored by follow-up blood testing using Hemocue's hemoglobin photometers to track changes in hemoglobin levels.
干预措施: Focal Mass Drug Administration with Primaquine (Drug)
结局指标
主要结局
Infection prevalence at 3-month intervals estimated through cross-sectional surveys
时间窗: upto 24 months
The primary outcome of the study was the reduction in the prevalence of infection in the study population in 3 and 6 months after the PQ MDA. Malaria prevalence was determined through cross-sectional surveys (CSSs) of the village populations one week before MDA to assess baseline infection prevalence and three and six months after the MDA. For each CSS, finger-prick blood was obtained from each participant to prepare two dried filter-paper blood spots (DBSs). DNA was extracted from the DBSs, and Plasmodium DNA was detected by nested PCR using species-specific primers. Per recommendations from the National Malaria Treatment Guidelines and because molecular detection was performed after the completion of the field studies, PCR-positive asymptomatic infections were not treated. Therefore, to determine malaria prevalence, six cross-sectional surveys were conducted, collecting blood samples from both groups at 3-month intervals between each round.
Monthly malaria incidence by passive case detection
时间窗: upto 24 months
The another outcome of the study was the incidence of clinical malaria within 6 months of PQ MDA. Clinical malaria cases were diagnosed using an RDT (SD BIOLINETM Malaria Ag P.f/P.v test) and recorded at either the villages by the Integrated Community Malaria Volunteers or the township hospital.
次要结局
未报告次要终点
研究者
Pyae Linn Aung
Secretary
Myanmar Health Network Organization