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Completed

NCT Number: NCT03648411

Drug Resistance Among Asymptomatic Infection

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Drug resistance molecular markers

Genetic

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

Primary outcomes

  1. Prevalence of the asymptomatic infection among the study population

    Time frame: 1 week

    Number of the hidden malaria cases by RDT, microscopy or nested PCR (molecular method)

  2. Proportion of the drug resistance molecular markers among asymptomatic infections

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Department of Medical Research, Lower Myanmar

Other

Collaborators

  • National Malaria Control Program, Myanmar

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Aug 27, 2018
Registry last updated
Jul 22, 2020

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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