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CompletedNCT03648411Updated Jul 22, 2020

Drug Resistance Among Asymptomatic Infection

An observational study in Drug Resistant Malaria, Asymptomatic Infections and Migrant Workers, sponsored by Department of Medical Research, Lower Myanmar. Completed at 1 site in Myanmar. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-22.

Sponsored by Department of Medical Research, Lower Myanmar · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
765
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Drug Resistant Malaria
  • Asymptomatic Infections
  • Migrant Workers

Keywords

  • malaria
  • falciparum
  • vivax
  • Myanmar
  • migrant workers
  • asymptomatic infection
  • drug resistance
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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).

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

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
04

Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
765 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • GeneticDrug resistance molecular markers

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

05

What researchers measure

Primary outcomes

  1. Prevalence of the asymptomatic infection among the study population

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

    Time frame: 1 week

  2. 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.

    Time frame: 3 months

06

Study locations

1 site
  • Dr. Myat Phone Kyaw
    Yangon, 11191, Myanmar
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03648411
Lead sponsor
Department of Medical Research, Lower Myanmar
Collaborators
National Malaria Control Program, Myanmar
Responsible party
Myat Htut Nyunt (Principal Investigator, Department of Medical Research, Lower Myanmar) — Principal investigator
First posted
Aug 27, 2018
Start date
Jan 12, 2019
Primary completion
Dec 30, 2019
Completion
May 20, 2020
Last update
Jul 22, 2020

Study contacts

Myat H Nyunt, PhD
principal investigator · Department of Medical Research

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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