Ignite Creation Date:
2024-05-06 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03689036
Status:
UNKNOWN
Last Update Posted:
2022-05-12
First Post:
2018-09-25
Brief Title:
Transmission Dynamics of Residual and Re-emerging Malaria in the Amazon Defining a Roadmap to Malaria Elimination
Sponsor:
Oswaldo Cruz Foundation
Organization:
Oswaldo Cruz Foundation
Study Overview
Official Title:
Transmission Dynamics of Residual and Re-emerging Malaria in the Amazon Defining a Roadmap to Malaria Elimination_Part A Acre Brazil
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 2000 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 MOHMinistry 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 smearRDT-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
The study will be developed in Mâncio Lima a residual malaria hotspot in northwestern Brazil The population of study is approximately 2000 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 MOHMinistry 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 smearRDT-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 10000 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 parentsguardians will be invited to participate in the cohort study
We expect to enroll 2000 subjects who will participate in 10 cross-sectional surveys every six months over five years total of 20000 observations and contribute 120000 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
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 10000 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 parentsguardians will be invited to participate in the cohort study
We expect to enroll 2000 subjects who will participate in 10 cross-sectional surveys every six months over five years total of 20000 observations and contribute 120000 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None