MalariaNCT03689036
Transmission Dynamics of Residual and Re-emerging Malaria in the Amazon: Defining a Roadmap to Malaria Elimination
An observational study of Malaria, run by Oswaldo Cruz Foundation at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months and older
- Conditions the study is for
- Malaria
- How many people
- 2,000 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Apr 2018to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
- Adults and children will both contribute to the data and study goals. Adults and children will both contribute to the data and study goals. Children less than three months of age will be excluded from the study because the heel or finger prick procedures to draw blood may be perceived by the parents as inappropriate for this age group. Children aged three months or more are eligible as long as they are members of the randomly chosen households and their parents/guardians provide informed consent. Inclusion of children is essential for the study goals, since different age groups may differ in acquired immunity and therefore in the risk of having symptoms when carrying malaria parasites
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transmission Dynamics of Residual and Re-emerging Malaria in the Amazon: Defining a Roadmap to Malaria Elimination_Part A: Acre, Brazil
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.
Read more
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.
Read the detailed description
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.
We expect to enroll ~ 2,000 subjects who will participate in 10 cross-sectional surveys (every six months) 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.
At each visit, the subjects will be interviewed and 100ul of blood will be collected to Active (ACD) and Passive Case Detection (PCD) (symptom based surveying; microscopy-based diagnosis). Each visit will include an interview, physical examination and collection of 100 μL of blood (finger prick) to malaria diagnosis by smear, RDT and qPCR.
When the subjects are 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 Ministry of Health of Brazil guidelines will be performed.
- Conditions
- Malaria
- Keywords
- malaria, transmission, Asymptomatic infeccion, malaria elimination, residual malaria, Amazon
- Medical subject headings
- Malaria
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2023
Secondary outcomes (2)
Genetic characterization of locally circulating malaria parasites over space and time
Determination of multilocus genotypes (using microsatellite markers) and complete genomes of Plasmodium vivax and Plasmodium falciparum isolates obtained from georeferenced households over the study period (5 years).
Measured: 2023
Estimating the impact of interventions to control and eliminate malaria.
Development and parametrization of mathematical models that incorporate risk heterogeneity in hosts to recapitulate major features of malaria transmission in the study site and estimate the impact of control measures (e.g., insecticide-treated bednet distribution, larviciding or improved antirelapse therapy for vivax malaria).
Measured: 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start2 Apr 2018
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oswaldo Cruz Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Principal investigator, Simone Ladeia, Oswaldo Cruz Foundation
- Investigators
- Marcelo U Ferreira, PhD MD, Study director, University of Sao Paulosimone l andrade, Phd MD, Study chair, Oswaldo Cruz Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689036
- Sponsor's protocol ID
- DMID 17-0037-A
- Status last verified
- May 2022
- First submitted
- 25 Sep 2018
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34789490
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transmission Dynamics of Residual and Re-emerging Malaria in the Amazon: Defining a Roadmap to Malaria Elimination_Part A: Acre, Brazil
- ClinicalTrials.gov ID
- NCT03689036
- Acronym / sponsor ID
- DMID 17-0037-A
- Conditions
- Malaria
- Keywords
- malaria, transmission, Asymptomatic infeccion, malaria elimination, residual malaria, Amazon
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Oswaldo Cruz FoundationUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
We expect to enroll ~ 2,000 subjects who will participate in 10 cross-sectional surveys (every six months) 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.
At each visit, the subjects will be interviewed and 100ul of blood will be collected to Active (ACD) and Passive Case Detection (PCD) (symptom based surveying; microscopy-based diagnosis). Each visit will include an interview, physical examination and collection of 100 μL of blood (finger prick) to malaria diagnosis by smear, RDT and qPCR.
When the subjects are 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 Ministry of Health of Brazil guidelines will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
- Adults and children will both contribute to the data and study goals. Adults and children will both contribute to the data and study goals. Children less than three months of age will be excluded from the study because the heel or finger prick procedures to draw blood may be perceived by the parents as inappropriate for this age group. Children aged three months or more are eligible as long as they are members of the randomly chosen households and their parents/guardians provide informed consent. Inclusion of children is essential for the study goals, since different age groups may differ in acquired immunity and therefore in the risk of having symptoms when carrying malaria parasites
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Risk factors for residual malaria infection and disease
Time frame: 2023
Determining sociodemographic variables that are significantly associated with malaria infection (regardless of symptoms) and clinical illness by multilevel multiple regression analysis
2 secondary outcomes
Genetic characterization of locally circulating malaria parasites over space and time
Time frame: 2023
Estimating the impact of interventions to control and eliminate malaria.
Time frame: 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Derived from this study: PubMed 34789490Johansen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcelo U Ferreira, PhD MD study director
University of Sao Paulo
simone l andrade, Phd MD study chair
Oswaldo Cruz Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, run by Oswaldo Cruz Foundation at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk factors for residual malaria infection and disease (time frame: 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03689036, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.