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Drug Resistance Among Asymptomatic Infection

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ClinicalTrials.gov Identifier: NCT03648411
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : January 29, 2020
Sponsor:
Collaborator:
National Malaria Control Program, Myanmar
Information provided by (Responsible Party):
Myat Htut Nyunt, Department of Medical Research, Lower Myanmar

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
Drug Resistant Malaria Asymptomatic Infections Migrant Workers 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.

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Study Type : Observational
Estimated Enrollment : 760 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 : January 12, 2019
Actual Primary Completion Date : December 30, 2019
Estimated Study Completion Date : March 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

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.




Primary Outcome Measures :
  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.


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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648411


Contacts
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Contact: MYAT H NYUNT, PhD +951-375447 ext 128 drmhnyunt@dmr-mm.org
Contact: AUNG THI, MSc +951-128749 aungthi08@gmail.com

Locations
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Myanmar
Dr. Myat Phone Kyaw Recruiting
Yangon, Myanmar, 11191
Contact: Myat P Kyaw, PhD    +951- 375457 ext 305    kyaw606@gmail.com   
Contact: Myat H Nyunt, MMedSc    +951-375447 ext 305    drmhnyunt@gmail.com   
Sponsors and Collaborators
Department of Medical Research, Lower Myanmar
National Malaria Control Program, Myanmar
Investigators
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Principal Investigator: Myat H Nyunt, PhD Department of Medical Research

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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: August 27, 2018    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Myat Htut Nyunt, Department of Medical Research, Lower Myanmar:
malaria
falciparum
vivax
Myanmar
migrant workers
asymptomatic infection
drug resistance
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Malaria
Asymptomatic Infections
Protozoan Infections
Parasitic Diseases
Asymptomatic Diseases
Disease Attributes
Pathologic Processes