Global and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Australia.
College of Medicine & Health Sciences, Arba Minch University, Arba Minch, Ethiopia.
Trials. 2022 May 18;23(1):416. doi: 10.1186/s13063-022-06364-z.
Plasmodium vivax forms dormant liver stages that can reactivate weeks or months following an acute infection. Recurrent infections are often associated with a febrile illness and can cause a cumulative risk of severe anaemia, direct and indirect mortality, and onward transmission of the parasite. There is an increased risk of P. vivax parasitaemia following falciparum malaria suggesting a rationale for universal use of radically curative treatment in patients with P. falciparum malaria even in the absence of detectable P. vivax parasitaemia in areas that are co-endemic for both species.
This is a multicentre, health care facility-based, randomized, controlled, open-label trial in Bangladesh, Indonesia and Ethiopia. Patients with uncomplicated falciparum malaria, G6PD activity of ≥70% of the adjusted male median (AMM) and haemoglobin levels ≥8g/dl are recruited into the study and randomized to either receive standard schizonticidal treatment plus 7-day high dose primaquine (total dose 7mg/kg) or standard care in a 1:1 ratio. Patients are followed up weekly until day 63. The primary endpoint is the incidence risk of any P. vivax parasitemia on day 63. Secondary endpoints include incidence risk on day 63 of symptomatic P. vivax malaria and the risk of any P. falciparum parasitaemia. Secondary safety outcomes include the proportion of adverse events and serious adverse events, the incidence risk of severe anaemia (Hb<5g/dl and <7g/dl) and/or the risk for blood transfusion, the incidence risk of ≥ 25% fall in haemoglobin with and without haemoglobinuria, and the incidence risk of ≥ 25% fall in haemoglobin to under 7g/dl with and without haemoglobinuria.
This study evaluates the potential benefit of a universal radical cure for both P. vivax and P. falciparum in different endemic locations. If found safe and effective universal radical cure could represent a cost-effective approach to clear otherwise unrecognised P. vivax infections and hence accelerate P. vivax elimination.
NCT03916003 . Registered on 12 April 2019.
间日疟原虫形成休眠的肝脏阶段，在急性感染后数周或数月可重新激活。复发性感染常伴有发热性疾病，并可导致严重贫血、直接和间接死亡率的累积风险，以及寄生虫的继续传播。在恶性疟原虫疟疾后，间日疟原虫寄生虫血症的风险增加，这表明在同时流行这两种物种的地区，即使在无法检测到间日疟原虫寄生虫血症的情况下，对恶性疟原虫疟疾患者使用根治性治疗也具有合理性。
这是一项在孟加拉国、印度尼西亚和埃塞俄比亚进行的多中心、医疗机构为基础、随机、对照、开放性临床试验。招募患有无并发症恶性疟原虫疟疾、G6PD 活性≥调整男性中位数（AMM）的 70%和血红蛋白水平≥8g/dl 的患者，并将其随机分为接受标准裂殖体杀灭治疗加 7 天高剂量伯氨喹（总剂量 7mg/kg）或标准护理，比例为 1:1。患者每周随访一次，直到第 63 天。主要终点是第 63 天任何间日疟原虫寄生虫血症的发生率风险。次要终点包括第 63 天有症状间日疟原虫疟疾的发生率风险和任何恶性疟原虫寄生虫血症的发生率风险。次要安全性结局包括不良事件和严重不良事件的比例、严重贫血（Hb<5g/dl 和<7g/dl）和/或输血风险的发生率风险、血红蛋白下降≥25%且无血红蛋白尿和血红蛋白下降≥25%且有血红蛋白尿的发生率风险、以及血红蛋白下降至<7g/dl 且无血红蛋白尿和血红蛋白下降至<7g/dl 且有血红蛋白尿的发生率风险。
本研究评估了在不同流行地区对间日疟原虫和恶性疟原虫进行普遍根治治疗的潜在益处。如果发现安全有效，普遍根治治疗可能代表一种具有成本效益的方法，可以清除未被识别的间日疟原虫感染，从而加速间日疟原虫的消除。
NCT03916003。于 2019 年 4 月 12 日注册。
