Drug Resistance Among Asymptomatic Infection

Assessment of Drug Resistance Molecular Markers in Asymptomatic Malaria Among Migrant Workers in Myanmar

A cross-sectional study will be conducted in selected 2 sentinel sites for assessment of drug resistance falciparum and vivax among asymptomatic infection in migrant workers in Myanmar.

Study Overview

• Status: Completed
• Conditions: Asymptomatic Infections; Drug Resistant Malaria; Migrant Workers
• Intervention / Treatment: Genetic: Drug resistance molecular markers

Detailed Description

Although malaria prevalence is decreasing in Myanmar, drug resistance threatens the malaria elimination by 2030 especially high risk persons including migrant population. Previous study indicated that asymptomatic malaria parasite carried drug resistance gene such as K13 mutant that is genetically responsible for artemisinin resistant falciparum malaria. These asymptomatic carries may be a source to spread the disease and it is very important to conduct the surveillance on drug resistance status among high vulnerable persons. Unfortunately, there is no study to assess the drug resistance molecular markers in asymptomatic malaria among migrant workers in Myanmar. Therefore, this study fulfills the gaps of knowledge on important of asymptomatic hidden infection exploring to formulate the recommendation for elimination of malaria in Myanmar.

In this study, asymptomatic infections are screened by rapid diagnostic test, microscopy and molecular methods.

• Study Type: Observational
• Enrollment (Actual): 765

Contacts and Locations

Study Locations

• Myanmar
  • Yangon, Myanmar, 11191
    • Dr. Myat Phone Kyaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The activity will cover the migrant population of the Shwegyin Township (Bago Region) and Pinlebu Township (Sagaing Region).

Description

Inclusion Criteria:

• Age above 6 year
• Migrant population (moving from their normal residence place and working at a new place such as forest related activities, gold-mines or plantation sites for more than 3 months- 3 years)
• Both sex
• Participant who give informed-consent to participate the study

Exclusion Criteria:

• Known clinical malaria cases regardless of the species detected
• Patients with clinical symptoms of malaria at the time of examination
• Known history of malaria within 14 days

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Shwegyin; Shwehyin is a Township in Bago Region. We will use the comparison between the two sentinel sites by the name of Shwegyin and Pinlebu. We will compare the prevalence of asymptomatic infection between these two sites. Then proportion of the drug resistance molecular markers will be compared.	Genetic: Drug resistance molecular markers; Proportion of the drug resistance molecular markers will be found-out and compared.
Pinlebu; Pinlebu is a township in Sagaing Region. We will use the comparison between the two sentinel sites by the name of Shwegyin and Pinlebu. We will compare the prevalence of asymptomatic infection between these two sites. Then proportion of the drug resistance molecular markers will be compared.	Genetic: Drug resistance molecular markers; Proportion of the drug resistance molecular markers will be found-out and compared.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of the asymptomatic infection among the study population	Number of the hidden malaria cases by RDT, microscopy or nested PCR (molecular method)	1 week
Proportion of the drug resistance molecular markers among asymptomatic infections	Among the asymptomatic cases, molecular markers will be analyzed (K13 and pfmdr1 copy number for falciparum and pvcrt-o, pvmdr1, pvdhps and pvdhfr gene analysis for vivax cases by Sanger Sequencing.	3 months

Collaborators and Investigators

• Sponsor: Department of Medical Research, Lower Myanmar
• Collaborators: National Malaria Control Program, Myanmar
• Investigators: Principal Investigator: Myat H Nyunt, PhD, Department of medical research

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 12, 2019
• Primary Completion (ACTUAL): December 30, 2019
• Study Completion (ACTUAL): May 20, 2020

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: August 24, 2018
• First Posted (ACTUAL): August 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: malaria; vivax; drug resistance; falciparum; migrant workers; asymptomatic infection; Myanmar
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Asymptomatic Diseases; Infections; Malaria; Asymptomatic Infections
• Other Study ID Numbers: DMR_2018-108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No