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Molecular Assessment of Drug Resistance Markers in Asymptomatic Malaria Cases and Malaria Antibody Kinetic

Molecular Assessment of Drug Resistance Markers in Asymptomatic Malaria Cases in Myanmar Artemisinin Resistance Containment Zones and Malaria Antibody Kinetic Analysis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02708199
Enrollment
1179
Registered
2016-03-15
Start date
2015-01-31
Completion date
2015-12-31
Last updated
2016-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asymptomatic Infection, Increased Drug Resistance, Malaria

Keywords

Drug resistance malaria, Myanmar Artemisinin Resistance Containment Zone, Asymptomatic malaria, Serology

Brief summary

Detection of the drug resistance molecular markers for falciparum and vivax in Longitudinal follow-up samples collected in Shwegyin Township, Bago Region that is Artemisinin Resistance Containment Tier I.

Detailed description

This study is longitudinal and observational cohort study to detect the drug resistance molecular markers in asymptomatic malaria infected local residents in study site. Only local residence who are not migrants, are recruited in the study and active and passive surveillance have been carried out within one year observation period. At the time of enrollment, blood film examination, rapid diagnosis test (RDT) testing have been done all together with the collection of the venous blood (about 1-2 mL) that would be used for molecular analysis later. All of the RDT or microscopy positive cases were treated according to the National Malaria Treatment Policy in Myanmar. A total of at least 1000 participants have been recruited in the study. Active case detection has been done in every three months. The venous blood were used for molecular based detection of the asymptomatic malaria infection by using High-throughout pooling strategy. All of the positive samples, (falciparum and vivax), have been checked for drug resistance molecular analaysis compared with the previously collected symptomatic malaria infection cases in the same region.

Interventions

None listed

Sponsors

Kangwon National University
CollaboratorOTHER
Department of Medical Research, Lower Myanmar
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Local resident in stud sites * Who give informed consent * No known tentative plan to move/ migrant elsewhere within one year

Exclusion criteria

* Migrant or mobile population * Less than 6 year

Design outcomes

Primary

MeasureTime frameDescription
Number of the Asymptomatic malaria infection2016 MarchNumber of the asymptomatic malaria infection by molecular method in the sample collected from apparently healthy individuals. It have been done by nested PCR based method. Number of the asymptomatic infection will be finished in March 2016. (up to up to 5 months after last samples collection)

Secondary

MeasureTime frameDescription
Number of the cases that showed drug resistance molecular markers in asymptomatic malaria infection2016 AprilK13, Pffd, Pfmdr2 and Pfcrt markers for falciparum and Pvcrt-O, Pvdhps, Pvdhfr and Pvmdr1 for vivax asymptomatic infections.The target sequences will be analysed to detect the specific single nucleotide polymorphism (SNPs). Molecular marker analysis will be done as soon as after asymptomatic infection have been confirmed. It will be finished in 2016 April. (up to 6 months after last sample collection)
Prevalence of the different Malaria Antibody in local resident in Myanmar2016 DecemberMalaria antibody that against the malaria parasites will be assessed by using high sensitive protein microarray. Total overall prevalence will be assessed and time to time change of the antibody status will be observed. It will be started in April until December 2016.(Up to 14 months after last sample collection)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026