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Completed

NCT Number: NCT02708199

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of the Asymptomatic malaria infection

    Time frame: 2016 March

    Number 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 outcomes

  1. Number of the cases that showed drug resistance molecular markers in asymptomatic malaria infection

    Time frame: 2016 April

    K13, 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)

  2. Prevalence of the different Malaria Antibody in local resident in Myanmar

    Time frame: 2016 December

    Malaria 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)

Sponsors and collaborators

Lead sponsor

Department of Medical Research, Lower Myanmar

Other

Collaborators

  • Kangwon National University

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 15, 2016
Registry last updated
Mar 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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