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

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.

Study Overview

• Status: Completed
• Conditions: Malaria; Increased Drug Resistance; Asymptomatic Infection

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.

• Study Type: Observational
• Enrollment (Actual): 1179

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Shwegyin Township, Bago Region, Myanmar Artemisinin resistance containment Zone I.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of the Asymptomatic malaria infection	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)	2016 March

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of the cases that showed drug resistance molecular markers in asymptomatic malaria infection	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)	2016 April
Prevalence of the different Malaria Antibody in local resident in Myanmar	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)	2016 December

Collaborators and Investigators

• Sponsor: Department of Medical Research, Lower Myanmar
• Collaborators: Kangwon National University

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: March 5, 2016
• First Submitted That Met QC Criteria: March 9, 2016
• First Posted (Estimate): March 15, 2016

Study Record Updates

• Last Update Posted (Estimate): March 15, 2016
• Last Update Submitted That Met QC Criteria: March 9, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Serology; Asymptomatic malaria; Drug resistance malaria; Myanmar Artemisinin Resistance Containment Zone
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Asymptomatic Diseases; Malaria; Asymptomatic Infections
• Other Study ID Numbers: KMRL_01_2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data may be shared after publish.