Fusco Daniela, Rakotozandrindrainy Raphäel, Rakotoarivelo Rivo Andry, Andrianarivelo Mala Rakoto, Rakotozandrindrainy Njary, Rasamoelina Tahinamandranto, Puradiredja Dewi Ismajani, Klein Philipp, Stahlberg Karl, Dechenaud Marie, Lorenz Eva, Jaeger Anna, Kreidenweiss Andrea, Hoekstra Pytsje T, Adegnika Akim Ayola, Sicuri Elisa, Corstjens Paul L A M, van Dam Govert J, May Jürgen, Schwarz Norbert Georg
Department of Infectious Diseases Epidemiology, Bernhard Nocht Institute for Tropical Medicine (BNITM), Bernhard-Nocht-Strasse 74, D-20359, Hamburg, Germany.
German Center for Infection Research (DZIF), Hamburg-Borstel-, Lübeck, Riems, Germany.
Trials. 2021 Nov 20;22(1):822. doi: 10.1186/s13063-021-05769-6.
Mass drug administration (MDA) of praziquantel is one of the main control measures against human schistosomiasis. Although there are claims for including pregnant women, infants and children under the age of 5 years in high-endemic regions in MDA campaigns, they are usually not treated without a diagnosis. Diagnostic tools identifying infections at the primary health care centre (PHCC) level could therefore help to integrate these vulnerable groups into control programmes. freeBILy (fast and reliable easy-to-use-diagnostics for eliminating bilharzia in young children and mothers) is an international consortium focused on implementing and evaluating new schistosomiasis diagnostic strategies. In Madagascar, the study aims to determine the effectiveness of a test-based schistosomiasis treatment (TBST) strategy for pregnant women and their infants and children up until the age of 2 years.
A two-armed, cluster-randomized, controlled phase III trial including 5200 women and their offspring assesses the impact of TBST on child growth and maternal haemoglobin in areas of medium to high endemicity of Schistosoma mansoni. The participants are being tested with the point of care-circulating cathodic antigen (POC-CCA) test, a commercially available urine-based non-invasive rapid diagnostic test for schistosomiasis. In the intervention arm, a POC-CCA-TBST strategy is offered to women during pregnancy and 9 months after delivery, for their infants at 9 months of age. In the control arm, study visit procedures are the same, but without the POC-CCA-TBST procedure. All participants are being offered the POC-CCA-TBST 24 months after delivery. This trial is being integrated into the routine maternal and child primary health care programmes at 40 different PHCC in Madagascar's highlands. The purpose of the trial is to assess the effectiveness of the POC-CCA-TBST for controlling schistosomiasis in young children and mothers.
This trial assesses a strategy to integrate pregnant women and their children under the age of 2 years into schistosomiasis control programmes using rapid diagnostic tests. It includes local capacity building for clinical trials and large-scale intervention research.
Pan-African Clinical Trial Register PACTR201905784271304. Retrospectively registered on 15 May 2019.
吡喹酮群体服药是控制人类血吸虫病的主要措施之一。尽管有人主张在高流行地区的群体服药活动中纳入孕妇、婴儿和5岁以下儿童，但通常在未确诊的情况下不会对他们进行治疗。因此，在初级卫生保健中心（PHCC）层面能够识别感染的诊断工具有助于将这些弱势群体纳入控制计划。freeBILy（用于消除幼儿和母亲血吸虫病的快速、可靠且易于使用的诊断方法）是一个国际联盟，专注于实施和评估新的血吸虫病诊断策略。在马达加斯加，该研究旨在确定基于检测的血吸虫病治疗（TBST）策略对孕妇及其2岁以下婴幼儿的有效性。
一项双臂、整群随机对照III期试验，纳入5200名妇女及其后代，评估TBST对曼氏血吸虫中度至高度流行地区儿童生长和母亲血红蛋白的影响。参与者使用即时检验循环阴极抗原（POC-CCA）检测进行检测，这是一种市售的基于尿液的血吸虫病非侵入性快速诊断检测。在干预组，在孕期和产后9个月为妇女提供POC-CCA-TBST策略，为9个月大的婴儿提供该策略。在对照组，研究访视程序相同，但不进行POC-CCA-TBST程序。所有参与者在产后24个月都可获得POC-CCA-TBST。该试验正在马达加斯加高地40个不同的初级卫生保健中心纳入常规母婴初级卫生保健计划。该试验的目的是评估POC-CCA-TBST对控制幼儿和母亲血吸虫病的有效性。
该试验评估了一项使用快速诊断检测将孕妇及其2岁以下儿童纳入血吸虫病控制计划的策略。它包括临床试验和大规模干预研究的当地能力建设。
泛非临床试验注册中心PACTR201905784271304。于2019年5月15日追溯注册。
