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临床试验/NCT03689036
NCT03689036Unknown不适用

Transmission Dynamics of Residual and Re-emerging Malaria in the Amazon: Defining a Roadmap to Malaria Elimination_Part A: Acre, Brazil

Oswaldo Cruz Foundation1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2018年4月2日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,000
试验地点
1
主要终点
Risk factors for residual malaria infection and disease

研究概览

简要总结

A population baseline longitudinal study in a major residual malaria hotspot in Brazil to: 1. identify risk factors for residual malaria infection and disease at individual and household level, 2. identify and quantify population changes in P. vivax and P. falciparum to detect reintroductions and to estimate parasite population complexity at baseline and after interventions and 3. describe changing dynamics of malaria incidence and parasitemia prevalence over time, and to assess potential effects of combinations of interventions on malaria control and elimination using mathematical models.

The study will be developed in Mâncio Lima, a residual malaria hotspot in northwestern Brazil. The population of study is approximately 2,000 subjects aged 3 months and up, who correspond to all the residents of 20% of the households of the urban area of Mâncio Lima.

Will be made Active (ACD) and Passive Case Detection (PCD) every 6 months, over 5 years. (symptom based surveying; microscopy-based diagnosis).

Each visit will include interview, physical examination and collection of 100 μL of blood (finger prick) to malaria diagnosis by smear, RDT and qPCR. If the subject will be positive by smear or RDT (rapid diagnostic test for malaria), despite of presence of symptoms, ≥ 20 mL of venous blood will be draw of them to immunology and parasite genetics study and the immediate treatment per MOH(Ministry of Health) guidelines will be performed.

Subjects with smear or RDT negative, will be followed for symptoms over the next 6 months. If it is subsequently found to be smear/RDT-positive by PCD, the treatment will be performed.

Clinical and epidemiological characteristics of malaria, genetic characteristics of the population of Plasmodium and changing dynamics of malaria transmission will be analyzed.

详细描述

Cross-sectional surveys will be carried out in order to identify risk factors for residual malaria infection and disease at both the individual and household level, to supply parasite samples for detailed population-level molecular analyses and to supply epidemiological data for parameterization of new mathematical models of malaria transmission.

SPECIFIC AIMS:

  • Aim 1: Longitudinally determine malaria dynamics in a major residual malaria hotspot in Brazil.

  • Aim 2: Identify and quantify population changes in P. vivax and P. falciparum to detect reintroductions, and to estimate parasite population complexity at baseline and potentially after interventions.

  • Aim 3: Develop and apply mathematical models to describe changing dynamics of malaria incidence and parasitemia prevalence over time, and to assess potential effects of combinations of interventions on malaria control and elimination.

  • The study will be developed in the urban area of Mâncio Lima, northwestern of Brazil.

A census performed by our field team between Nov 2015 and Apr 2016 identified ~ 10,000 inhabitants in the urban area of Mâncio Lima. At the site preparation phase, a random sample of 20% of the households enumerated during our census will be visited by our field teams and all dwellers aged 3 months or up (or their parents/guardians) will be invited to participate in the cohort study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
3 Months 至 —(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

结局指标

主要结局

Risk factors for residual malaria infection and disease

时间窗: 2023

Determining sociodemographic variables that are significantly associated with malaria infection (regardless of symptoms) and clinical illness by multilevel multiple regression analysis

次要结局

  • Genetic characterization of locally circulating malaria parasites over space and time(2023)
  • Estimating the impact of interventions to control and eliminate malaria.(2023)

研究者

发起方
Oswaldo Cruz Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Simone Ladeia

Investigator

Oswaldo Cruz Foundation

研究点 (1)

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