A Randomized, Placebo-controlled, Double-blind Trial Using Dihydroartemisinine+Piperaquine (DP) to Protect Forest Workers From Malaria in Bu Gia Map National Park
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- the proportion of study subjects with any malaria parasitaemia (P.falciparum, mixed parasitaemia of P.falciparum and P.vivax) and the incidence rate of symptomatic malaria
研究概览
简要总结
The purpose of the study is to assess if the antimalarial drugs Dihydroartemisinine + Piperaquine (DP) are effective in preventing malaria infection for forest ranger
详细描述
To assess the protective effect of 3-day DP regimen for forest rangers working for long-term in forest where malaria transmission is intense, all eligible forest rangers will be treated with a full course of DP + primaquine to eradicate all parasites which may survive in their blood while staying in non- malaria transmission areas.
Just before returning back to the forest participants will be randomized to receive either Arterakine (dihydroartemisinine (DHA)/piperaquine) (intervention arm) or placebo (control arm). Participants will be assessed for parasitemia before and after the forest trip with high volume, ultrasensitive, PCR (HVUqPCR). The minimum time span between two forest trips should be 20 days so participants could complete the 14 day primaquine course and the Arterakine (dihydroartemisinine (DHA)/piperaquine).
There is no limit in the duration between trips. Participants are tested for P.falciparum, P.vivax infection before they return to the forest.
Each participant will be visited 2 weeks or later after returning home from the forest and examined. The rationale for the added two weeks is to detect blood stages of infections, which may have been inoculated towards the end of the forest visit.
If found to be sick, the patient will be treated according to government treatment guidelines. A 4ml venous blood sample will be obtained for Hb and HVUSqPCR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Informed consent
- •Male, over or equal to18 years of age
- •Able and willing to comply with the study requirements and follow-up
排除标准
- •Inability to tolerate oral treatment
- •Previous episode of haemolysis or severe haemoglobinuria following primaquine
- •Glucose-6-phosphate dehydrogenase (G6PD) deficient with Hb < 9 g/dL *
- •Known hypersensitivity or allergy to any study drugs * If the participant with G6PD deficient gets malaria, primaquine would be used as recommended by World Health Organization (WHO) (once a week for 8 weeks) in combination with 3 days of chloroquine.
研究组 & 干预措施
Arterakine
Active drug: Arterakine (DHA/piperaquine) one tablet contains 40 mg of dihydroartemisinin and 320 mg piperaquine. Weight based regimen: 7 mg/kg dihydroartemisinin; 55 mg/kg piperaquine phosphate) for 3 days prior to forest visit (day -2, -1 and day 0 prior forest visit)
干预措施: Arterakine (DHA/piperaquine) (Drug)
Placebo
Placebo (visually matched to Arterakine for 3 days prior to forest visit (day -2, -1 and day 0 prior forest visit)
干预措施: Placebo (Drug)
结局指标
主要结局
the proportion of study subjects with any malaria parasitaemia (P.falciparum, mixed parasitaemia of P.falciparum and P.vivax) and the incidence rate of symptomatic malaria
时间窗: at 2 weeks after coming back from the forest
The primary endpoints are the proportion of study subjects with any malaria parasitaemia (P.falciparum, mixed parasitaemia of P.falciparum and P.vivax) at 2 weeks after coming back from the forest assessed by high volume, ultrasensitive PCR (HVUSqPCR) and the incidence rate of symptomatic malaria (P.falciparum, mixed P.falciparum + P.vivax) during the two week follow-up period as assessed by the study doctor.
次要结局
- The proportion of different anopheles species amongst all captured mosquito anopheles(1 month)
- The proportion of sporozoite-carrying mosquitoes (any parasite, P.falciparum, mixed P.falciparum and P.vivax)(6 months)