Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03689036 |
| Other study ID # |
DMID 17-0037-A |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 2, 2018 |
| Est. completion date |
July 31, 2024 |
Study information
| Verified date |
May 2022 |
| Source |
Oswaldo Cruz Foundation |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
