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临床试验/NCT07281443
NCT07281443进行中(未招募)不适用

Mass Drug Administration and Targeted Control Against Carriage to Reduce Plasmodium Transmission in the Sahel - Administration de Masse d'Antipaludiques et Lutte ciblée Contre le Portage Pour REduire la Transmission de Plasmodium au Sahel

Institut de Recherche pour le Developpement1 个研究点 分布在 1 个国家目标入组 18,000 人开始时间: 2024年9月23日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
18,000
试验地点
1
主要终点
Plasmodium falciparum carriage reservoir at the end of the high transmission season (step 0)

研究概览

简要总结

Strategies implemented since 2010 by the Senegalese National Malaria Control Program (NMCP) enabled a reduction of malaria transmission. However, malaria incidence increased again in recent years, especially in the "red zone" of Kedougou, Kolda and Tambacounda regions. Neighbouring Sahelian countries also documented an increase in malaria incidence in the same period. Current interventions include : long-lasting insecticidal nets, free diagnostic and treatment of clinical malaria, home-based case management (PECADOM), intermittent preventive treatment of pregnant women and seasonal malaria chemoprevention for children up to 10 years. These strategies, while efficient to reduce the burden of clinical malaria, do not account for individuals chronically infected with Plasmodium parasites. These carriers often remain asymptomatic and act as a reservoir for persistence during the dry season, and onwards transmission during the wet season. An observational study conducted in Kedougou in 2021 and 2022 by IRD Dakar shed light on the most affected age groups and on risk-factors associated with asymptomatic carriage.

Interventions against asymptomatic carriage could complement existing strategies and contribute to reducing malaria transmission. Mass drug administration (MDA) involves proposing a curative treatment of each member of the community, regardless of age, during a coordinated campaign. To this day, it is the only intervention available to deplete the reservoir of Plasmodium carriers, since a large proportion of asymptomatic infections remain undetectable with available field tests. A study conducted by NMCP and Iba Der Thiam University in Thiès (UIDT) in 2021 in Tambacounda showed that regular MDA campaigns during the high transmission season had a significant impact on clinical malaria incidence and on prevalence of carriage.

AMARETi project aims to evaluate an intervention to complete current control strategies. The design of this intervention combines the recent results from Kedougou and Tambacounda studies. The intervention consists of an MDA campaign at the start and at the end of the high transmission season, aiming at maximal depletion of the asymptomatic reservoir, and of age-group targeted interventions aiming to reduce chronic reinfection in individuals at highest risk of asymptomatic carriage.

The design and implementation of the intervention stem from a co-construction process with members of communities participating in the research, to maximize inclusiveness and adhesion. It aims to ensure the design of interventions that are adapted to age, gender and other factors deemed relevant by researchers and communities.

The project will evaluate if this intervention improves significantly the situation compared to current strategy in a stepped-wedge cluster-randomized controlled trial over 2 malaria high transmission seasons. If the results are conclusive, recommendations for scale-up can be made. The primary outcome will be Plasmodium falciparum infection prevalence at the end of the high transmission season. Secondary outcomes include clinical malaria incidence and malaria incidence dynamics, as well as participation, safety and acceptability.

Implementation outcomes (not detailed here) will include the assessment of implementation (CFIR's indicators), sustainability (Schell's indicators) and scalability (Coroa's indicators). These indicators use multiple dimensions stemming from qualitative and quantitative data and flexible design to understand each specific outcome (Proctor E, et al, Mental Health and Mental Health Services Research 2011).

In addition, a nested study in 10 villages will provide insights on transmission and reservoir restoration mechanisms through follow-up of a cohort and in-depth investigations.

AMARETi project will take place from 2024 to 2027 in 7 health posts and 50 villages of Kedougou department, under the leadership of the Kedougou Health District and Region authorities. The local health, administrative and community-based authorities at local and regional level are also key partners in the project, as well as local development committees and health community-based organisations. Healthpost staff and community health workers and volunteers will be essential for the operational field implementation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

年龄范围
3 Months 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

MDA and targeted control

Experimental

Interventions:

  • MDA with DHAp and SLD Primaquine
  • Targeted control (10-24 years) during the malaria high tranmission season: behaviour
  • Targeted control (15-24 years) during the malaria high tranmission season: test and treat

During intervention period, villages receive 2 rounds of MDA simultaneously to SMC rounds 1 and 5. SMC-eligible children participate in MDA in replacement of round 1 and 5, but receive SMC rounds 2, 3 and 4 routinely.

Youth-targeted control activities take place during the high transmission season: behavioural activies throughout and testing of asymptomatic young adults from 1 month after MDA1 to 1 month before MDA2.

干预措施: MDA with DHAp and SLD Primaquine (Drug)

结局指标

主要结局

Plasmodium falciparum carriage reservoir at the end of the high transmission season (step 0)

时间窗: 4 months after SMC round 1, baseline year 0

Number of participants with P. falciparum infection (measured by qPCR in cross sectional sample). Survey conducted at step 0 (baseline, year 0, no intervention). Survey takes place 4 months after SMC round 1 i.e. immediately before SMC round 5.

Plasmodium falciparum carriage reservoir at the end of the high transmission season (step 1)

时间窗: 4 months after MDA1/SMC round 1, year 1

Number of participants with P. falciparum infection (measured by qPCR in cross sectional sample). Surveys conducted at step 1 (year 1, intervention in 50% of clusters). Survey takes place 4 months after SMC round 1 in control villages (i.e. immediately before SMC round 5) and 4 months after MDA1 in intervention villages (i.e. immediately before MDA2).

Plasmodium falciparum carriage reservoir at the end of the high transmission season (step 2)

时间窗: 4 months after MDA3, year 2

Number of participants with P. falciparum infection (measured by qPCR in cross sectional sample). Surveys conducted at step 2 (year 2). During the final step, intervention MDA3 (at the start of the wet season, replacing SMC round 1) and MDA4 (at the end of the wet season, replacing SMC round 5) take place in all clusters. Survey takes place 4 months after MDA3 in intervention villages (i.e. immediately before MDA4).

Odds ratio of P. falciparum infection associated with intervention/control period status

时间窗: 4 months after SMC round 1, years 0, 1 and 2

The results of the cross sectional surveys at year 0, 1 and 2 (see outcomes 1-3) will be analysed in a multivariable multilevel logistic regression model. Explained variable : P. falciparum infection detected by qPCR. Variable of interest : intervention or control status at village level. Adjustments for individual, household, and cluster-level fixed effects. Including household, village, cluster and temporal random effects.

次要结局

  • Plasmodium falciparum carriage reservoir at the onset of the high transmission season (step 2)(immediately before MDA3, year 2)
  • Plasmodium falciparum carriage reservoir at the onset of the high transmission season (step 1)(immediately before MDA1/SMC round 1, year 1)
  • Clinical malaria burden(year 1, year 2)
  • Spatio-temporal dynamics of clinical malaria incidence(year 1, year 2)
  • Mass drug administration safety (active)(Day 4 after MDA start)
  • Mass drug administration safety (passive)(Day 0 to day 7 after MDA start)
  • Plasmodium falciparum infection prevalence in 10-14 and 15-24 years(4 months after MDA3, year 2)
  • Intervention cost-effectiveness(year 2 and year 3)
  • Participation to MDA intervention(Day 5 after MDA (MDA1 & MDA2, year 1; MDA2 & MDA3, year 2).)
  • Participation to targeted control intervention (15-24 years)(from month 2 to month 3 MDA1 (year 2) ; from month 2 to month 3 after MDA3 (year 2))
  • Intervention acceptability(after MDA, year 1)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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