Permethrin-treated baby wraps for the prevention of malaria: results of a randomized controlled pilot study in rural Uganda.
Permethrin-treated baby wraps for the prevention of malaria: results of a randomized controlled pilot study in rural Uganda.
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DOI：
10.1186/s12936-022-04086-w
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发表时间：
2022-02-23
期刊：
影响因子：
3
通讯作者：
Mulogo EM
中科院分区：
文献类型：
--
作者：
Boyce RM;Muhindo E;Baguma E;Muhindo R;Shem B;François R;Hawke S;Shook-Sa BE;Ntaro M;Nalusaji A;Nyehangane D;Reyes R;Juliano JJ;Siedner MJ;Staedke SG;Mulogo EM
在疟疾负担重的国家，防治疟疾的进展已经停滞，甚至可能出现倒退。这是由于一系列因素造成的，包括杀虫剂抗药性和蚊子喂养行为，这些因素限制了人们接触广泛采用的干预措施，包括长效驱虫蚊帐和室内滞留喷洒。因此，迫切需要在疟疾控制方面进一步创新。该试验是一项随机、安慰剂对照的试验性研究，在乌干达西部农村的一个地点对6-18个月大的儿童进行氯菊酯处理的婴儿裹布（当地称为lesus）。将50对母婴以1：1的比例分配到氯菊酯处理或未处理的lesus中。参与者和临床工作人员通过使用假治疗和再治疗lesus对组分配不知情。参与者每2周参加一次预定的诊所访视，共12周。主要关注的结果是干预的安全性，评估为使用频率、停药率和不良事件（如皮疹）发生率的变化。次要结果包括干预的可接受性和可行性，分别通过参与者满意度和研究活动的完成来衡量。总体而言，保留率和参与率相对较高，86.0%（43/50）的参与者完成了所有计划访视，其中干预组和对照组分别有18例（75.0%）和25例（96.2%）。在12周随访期结束时，报告了1起不良事件（0.35起事件/100人-周，单侧95% CI 0.0-1.65）。两组患者对莱苏的满意度都很高。在每个研究组中，有5个事件RDT阳性结果，但仅在对照组中观察到PCR阳性结果（n = 2）。氯菊酯处理过的婴儿裹巾耐受性良好，可广泛接受。不良事件不常见且轻微。这些研究结果支持未来的试验，以确定治疗包裹预防幼儿恶性疟原虫疟疾感染的有效性，作为现有家庭干预措施的补充工具。试验注册：ClinicalTrials.gov标识符：NCT 04102592，注册日期：2019年9月25日。https://clinicaltrials.gov/ct2/show/NCT04102592在线版本包含补充材料，可在10.1186/s12936-022-04086-w查阅。
Progress against malaria has stalled and may even be slipping backwards in high-burden countries. This is due to a range of factors including insecticide resistance and mosquito feeding behaviours that limit contact with widely-employed interventions including long-lasting insecticidal nets and indoor-residual spraying. Thus, further innovations in malaria control are urgently needed. The pilot was a randomized, placebo-controlled pilot study of permethrin-treated baby wraps—known locally as lesus—in children 6–18 months of age at a single site in rural western Uganda. Fifty mother–infant pairs were assigned to permethrin-treated or untreated lesus in a 1:1 allocation. Participants and clinical staff were blinded to group assignments through use of sham treatment and re-treatment of lesus. Participants attended scheduled clinic visits every 2 weeks for a total 12 weeks. The primary outcome of interest was the safety of the intervention, assessed as changes in the frequency of use, rates of discontinuation, and incidence of adverse events, such as skin rash. Secondary outcomes included acceptability and feasibility of the intervention as measured through participant satisfaction and completion of study activities, respectively. Overall, rates of retention and participation were relatively high with 86.0% (43 of 50) of participants completing all scheduled visits, including 18 (75.0%) and 25 (96.2%) in the intervention and control arms respectively. By the conclusion of the 12-week follow-up period, one adverse event (0.35 events per 100 person-weeks, one-sided 95% CI 0.0–1.65) was reported. Satisfaction with the lesu was high in both groups. In each study arm, there were five incident RDT positive results, but the only PCR-positive results were observed in the control group (n = 2). Permethrin-treated baby wraps were well-tolerated and broadly acceptable. Adverse events were infrequent and mild. These findings support future trials seeking to determine the efficacy of treated wraps to prevent P. falciparum malaria infection in young children as a complementary tool to existing household-based interventions. Trial registration: ClinicalTrials.gov Identifier: NCT04102592, Registered 25 September 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT04102592 The online version contains supplementary material available at 10.1186/s12936-022-04086-w.
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影响因子：
3
作者：
Boyce RM;Muiru A;Reyes R;Ntaro M;Mulogo E;Matte M;Siedner MJ
通讯作者：
Siedner MJ
影响因子：
7.7
作者：
Huho, Bernadette;Briet, Olivier;Killeen, Gerry
通讯作者：
Killeen, Gerry
影响因子：
15.8
作者：
Griffin, Jamie T.;Hollingsworth, T. Deirdre;Ghani, Azra C.
通讯作者：
Ghani, Azra C.
影响因子：
9.4
作者：
Kassaza, Kennedy;Operario, Darwin J.;Boum, Yap, II
通讯作者：
Boum, Yap, II
影响因子：
3.8
作者：
Kittayapong, Pattamaporn;Olanratmanee, Phanthip;Wilder-Smith, Annelies
通讯作者：
Wilder-Smith, Annelies