Drug Resistance Among Asymptomatic Infection

Sponsor
Department of Medical Research, Lower Myanmar (Other)
Overall Status
Completed
CT.gov ID
NCT03648411
Collaborator
National Malaria Control Program, Myanmar (Other)
765
1
16.2
47.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
765 participants
Observational Model:
Ecologic or Community
Time Perspective:
Cross-Sectional
Official Title:
Assessment of Drug Resistance Molecular Markers in Asymptomatic Malaria Among Migrant Workers in Myanmar
Actual Study Start Date :
Jan 12, 2019
Actual Primary Completion Date :
Dec 30, 2019
Actual Study Completion Date :
May 20, 2020

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Prevalence of the asymptomatic infection among the study population [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dr. Myat Phone Kyaw Yangon Myanmar 11191

Sponsors and Collaborators

  • Department of Medical Research, Lower Myanmar
  • National Malaria Control Program, Myanmar

Investigators

  • Principal Investigator: Myat H Nyunt, PhD, Department of Medical Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Myat Htut Nyunt, Principal Investigator, Department of Medical Research, Lower Myanmar
ClinicalTrials.gov Identifier:
NCT03648411
Other Study ID Numbers:
  • DMR_2018-108
First Posted:
Aug 27, 2018
Last Update Posted:
Jul 22, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Myat Htut Nyunt, Principal Investigator, Department of Medical Research, Lower Myanmar
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 22, 2020