NCT03648411

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
765

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

January 12, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2020

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

12 months

First QC Date

August 23, 2018

Last Update Submit

July 21, 2020

Conditions

Keywords

malariafalciparumvivaxMyanmarmigrant workersasymptomatic infectiondrug resistance

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

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

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

Interventions

Proportion of the drug resistance molecular markers will be found-out and compared.

PinlebuShwegyin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Myat Phone Kyaw

Yangon, 11191, Burma

Location

Biospecimen

Retention: SAMPLES WITH DNA

The DNA samples will be kept at -80 degree C according to the consent of the participants. The samples will be kept with code number and limited restricted for use in future research.

MeSH Terms

Conditions

Asymptomatic InfectionsMalaria

Condition Hierarchy (Ancestors)

InfectionsAsymptomatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsProtozoan InfectionsParasitic DiseasesMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Myat H Nyunt, PhD

    Department of Medical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 23, 2018

First Posted

August 27, 2018

Study Start

January 12, 2019

Primary Completion

December 30, 2019

Study Completion

May 20, 2020

Last Updated

July 22, 2020

Record last verified: 2020-07

Locations