Centre for Child Health and Department of Child Health, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Jl. Kesehatan no.1, Sekip, Yogyakarta, 55284, Indonesia.
Timika Malaria Research Facility, Papuan Health and Community Development Foundation, Jl. SP2-SP5, RSMM Area, Timika, Papua, 99910, Indonesia.
BMC Med. 2022 Jun 8;20(1):190. doi: 10.1186/s12916-022-02394-1.
In Papua (Indonesia), infants with P. falciparum and/or P. vivax malaria are at risk of severe anaemia and death. We hypothesized that in an area of high malaria transmission, intermittent screening and treatment of infants with malaria (ISTi) will reduce morbidity compared to passive case detection (PCDi).
We conducted a cluster randomised, open label, superiority trial. A total of 21 clusters of village health posts (VHP) were randomised 1:1 to either IST for infants coinciding with 4 routine immunisation visits or PCDi. Healthy term infants born to consenting mothers enrolled into a maternal malaria cluster randomised trial were included in the study and followed for 12 months. Point of care malaria rapid diagnostic tests were used to detect peripheral parasitaemia at 2, 3, 4 and 9 months old in all infants in ISTi clusters and when symptomatic in PCDi clusters. Infants with detected peripheral parasitaemia were treated with dihydroartemisinin-piperaquine. The co-primary outcomes were the incidence rate of clinical malaria in the first year of life and the prevalence of parasitaemia at age 12 months. The incidence rate ratio and prevalence ratio between ISTi and PCDi were estimated using mixed-effects Poisson and log-binomial regression modelling (accounting for clustering at VHP level).
Between May 2014 and February 2017, 757 infants were enrolled into the study, 313 into 10 ISTi clusters, and 444 into 11 PCDi clusters. Overall, 132 episodes of parasitaemia were detected, of whom 17 (12.9%) were in symptomatic infants. Over 12 months, the incidence rate (IR) of clinical malaria was 24 [95% CI, 10-50] per 1000 children-years at risk in the ISTi arm and 19 [95% CI, 8,38] per 1000 children-years in the PCDi arm (adjusted incidence rate ratio [aIRR] 1.77 [95% CI, 0.62-5.01]; p = 0.280). The prevalence of parasitaemia at 12 months was 13% (33/254) in the IST clusters and 15% (57/379) in the PCD clusters (adjusted prevalence ratio (aPR) = 0.92 (95% CI, 0.70-1.21), p = 0.55). There was no difference in the risk of anaemia between treatment arms.
In high malaria transmission area outside of Africa, our study suggests that compared to PCDi, ISTi offers no significant benefit in reducing the risk of clinical malaria in infants born to women receiving effective protection from malaria during pregnancy.
ClinicalTrials.gov NCT02001428 , registered on 20 Nov 2013.
在巴布亚（印度尼西亚），患有恶性疟原虫和/或间日疟原虫疟疾的婴儿有发生严重贫血和死亡的风险。我们假设，在疟疾高度传播的地区，与被动病例检出（PCDi）相比，对患有疟疾的婴儿进行间歇性筛查和治疗（ISTi）将降低发病率。
我们进行了一项集群随机、开放标签、优效性试验。总共 21 个村卫生所集群被随机分为 1:1 的 ISTi 组和 PCDi 组。同意参加母亲疟疾集群随机试验的健康足月婴儿被纳入研究，并随访 12 个月。在所有 ISTi 集群的婴儿在 2、3、4 和 9 个月大时，以及在 PCDi 集群的婴儿出现症状时，使用即时检验疟疾快速诊断检测来检测外周寄生虫血症。在检测到外周寄生虫血症的婴儿中，使用二氢青蒿素-哌喹进行治疗。主要结局是婴儿在生命的第一年的临床疟疾发病率和 12 个月时的寄生虫血症患病率。使用混合效应泊松和对数二项式回归模型（考虑到 VHP 水平的聚类）估计 ISTi 和 PCDi 之间的发病率比值和患病率比值。
2014 年 5 月至 2017 年 2 月，共有 757 名婴儿参加了这项研究，313 名婴儿参加了 10 个 ISTi 集群，444 名婴儿参加了 11 个 PCDi 集群。总的来说，检测到 132 例寄生虫血症，其中 17 例（12.9%）为有症状的婴儿。在 12 个月期间，ISTi 组的临床疟疾发病率为每 1000 名儿童年 24 例（95%CI，10-50），PCDi 组为每 1000 名儿童年 19 例（95%CI，8，38）（调整发病率比值 [aIRR] 1.77 [95%CI，0.62-5.01]；p=0.280）。12 个月时，IST 集群的寄生虫血症患病率为 13%（33/254），PCD 集群为 15%（57/379）（调整后的患病率比值[aPR]=0.92（95%CI，0.70-1.21），p=0.55）。在贫血风险方面，两组之间没有差异。
在非洲以外的疟疾高度传播地区，我们的研究表明，与 PCDi 相比，ISTi 并不能显著降低接受妊娠期间有效疟疾保护的妇女所生婴儿发生临床疟疾的风险。
ClinicalTrials.gov NCT02001428，于 2013 年 11 月 20 日注册。
Zotero 插件