Transmission Dynamics of Residual and Re-emerging Malaria in the Amazon: Defining a Roadmap to Malaria Elimination

NCT03689036 | Unknown

• 1 other identifier: DMID 17-0037-A
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malaria

Keywords

malaria; transmission; Asymptomatic infeccion; malaria elimination; residual malaria; Amazon

Outcome Measures

Primary Outcomes (1)

• Risk factors for residual malaria infection and disease

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

  2023

Secondary Outcomes (2)

• Genetic characterization of locally circulating malaria parasites over space and time

  2023

• Estimating the impact of interventions to control and eliminate malaria.

  2023

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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. We expect to enroll \~ 2,000 subjects who will participate in 10 cross-sectional surveys over five years (total of 20,000 observations), and contribute 120,000 person-months of follow-up. Because of the open-cohort design of this study, subjects who are lost for follow-up are replaced with newcomers, without affecting significantly the number of person-months of follow-up.

You may qualify if:

• Any subject aged 3 or more months old living in the study sites and providing written informed consent, or with parental written informed consent and assent when age-appropriate;
• Plans to remain in the study site for the next five years.

You may not qualify if:

• any chronic or acute condition that, in the opinion of the field clinician or nurse, may affect the results of the study or the ability of providing informed consent.
• Less then 3 months old
• Do not have permanent residence in the study area

Sponsors & Collaborators

• Oswaldo Cruz Foundation: lead
• University of Sao Paulo: collaborator

Study Sites (1)

Marcelo Urbano Ferreira

São Paulo, 05508900, Brazil

Location

Related Publications (1)

• Johansen IC, Rodrigues PT, Tonini J, Vinetz J, Castro MC, Ferreira MU. Cohort profile: the Mancio Lima cohort study of urban malaria in Amazonian Brazil. BMJ Open. 2021 Nov 17;11(11):e048073. doi: 10.1136/bmjopen-2020-048073.

  PMID: 34789490 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasmodium vivax and Plasmodium falciparum

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Marcelo U Ferreira, PhD MD

  University of Sao Paulo

  STUDY DIRECTOR

• simone l andrade, Phd MD

  Oswaldo Cruz Foundation

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: September 28, 2018
• Study Start: April 2, 2018
• Primary Completion: October 31, 2023
• Study Completion: July 31, 2024
• Last Updated: May 12, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)