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临床试验/NCT06599593
NCT06599593
进行中(未招募)
不适用

Leveraging the Seasonal Malaria Chemoprevention Platform to Address Malaria and Malnutrition

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 438 人2025年7月3日

概览

阶段
不适用
干预措施
SQ-LNS
疾病 / 适应症
Malaria Incidence
发起方
University of California, San Francisco
入组人数
438
试验地点
1
主要终点
Clinical malaria incidence
状态
进行中(未招募)
最后更新
上个月

概览

简要总结

In the Sahel, the malaria and malnutrition seasons overlap during the rainy season, from approximately July through October. Malaria transmission increases due to the rain and collection of standing water and malnutrition risk increases because this period is the growing season, leading up to the annual harvest in November. Seasonal malaria chemoprevention (SMC) is an antimalarial intervention that involves monthly distribution of sulfadoxine-pyrimethamine (SP) and amodiaquine (AQ) to children aged 3-59 months during the high malaria transmission season. SMC is distributed to millions of children annually in 13 countries in the Sahel, including Burkina Faso. Although SMC distribution is highly effective against clinical malaria in children, malaria remains a major cause of childhood mortality and morbidity in Burkina Faso. The SMC platform, which involves monthly door-to-door delivery of SP-AQ, is an attractive platform for delivery of additional interventions that may augment child health during this vulnerable season. Malaria and malnutrition co-occur in children and communities, and interventions for one may affect the other. For example, previous work by our group and others has shown that antimalarial treatments may improve weight gain in children with malnutrition. The pilot trial is designed to evaluate how the SMC platform may be leveraged to deliver co-interventions with SMC that may augment its efficacy and reduce the incidence of malaria and malnutrition. It is anticipated that the results of this study will provide formative data for the development and implementation of a full-scale study evaluating the effects of integration of nutritional interventions on the SMC platform. It is anticipated that such a strategy may provide optimal protection for children during the most vulnerable period of the year by delivering interventions monthly on an existing platform that directly reaches millions of children each month.

注册库
clinicaltrials.gov
开始日期
2025年7月3日
结束日期
2026年10月30日
最后更新
上个月
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

入排标准

入选标准

  • Children will be eligible for inclusion in the trial if they meet all of the following criteria:
  • Live in the study community
  • Eligible for SMC
  • No allergy to peanuts or cow's milk
  • Able to orally feed
  • Within the eligible age ranges:
  • 6-59 months for passive surveillance
  • 6-24 months for SQ-LNS provision
  • Written informed consent from at least one caregiver
  • Caregiver is at least 18 years of age

排除标准

  • 未提供

研究组 & 干预措施

Nutrition-Intervention-SMC Integration

In conjunction with SMC administration, CHWs screen children for MUAC. CHW refers children with MUAC \<12.5 to the CSPS for MAM/SAM care and to receive all standard nutritional program. CHW provides all children ages 6-24 months who do not have acute malnutrition with SQ-LNS (Enov'nutributter; Nutriset; 20 g/day, approximately 100-120 calories).

干预措施: SQ-LNS

Nutrition-Intervention-SMC Integration

In conjunction with SMC administration, CHWs screen children for MUAC. CHW refers children with MUAC \<12.5 to the CSPS for MAM/SAM care and to receive all standard nutritional program. CHW provides all children ages 6-24 months who do not have acute malnutrition with SQ-LNS (Enov'nutributter; Nutriset; 20 g/day, approximately 100-120 calories).

干预措施: Integrated Nutritional Screening

Standard of Care Plus SQ-LNS Provision

Separately from SMC administration, CHWs screen children ages 6-59 months for MUAC as part of their routine program. CHW refers children with MUAC \<12.5 to the CSPS for MAM/SAM care and to receive all standard nutritional program. CHW provides all children ages 6-24 months who do not have acute malnutrition with SQ-LNS (Enov'nutributter; Nutriset; 20 g/day, approximately 100-120 calories).

干预措施: SQ-LNS

结局指标

主要结局

Clinical malaria incidence

时间窗: 5 months

The primary outcome will be the cumulative incidence of clinical malaria, defined as fever (temperature ≥37.5°C) plus a positive RDT, over the course of one SMC season. The primary outcome will be measured in two ways: active case detection and passive detection. For active surveillance, 25 children aged 6-24 months per community (N=500 total) will be randomly selected for biweekly monitoring for malaria using an HRP2-based RDT. For passive surveillance, we will record all uncomplicated malaria diagnoses at primary healthcare facilities.

次要结局

  • Alternative malaria Indicators(5 months)
  • Severe malaria(5 months)
  • All-cause clinic visits.(5 months)

研究点 (1)

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