Drug Resistance Among Asymptomatic Infection

Completed

• Conditions: Drug Resistant Malaria; Migrant Workers; Asymptomatic Infections
• Interventions: Genetic: Drug resistance molecular markers

• Registration Number: NCT03648411
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-08-24
• Study First Posted: 2018-08-27
• Study Start: 2019-01-12
• Primary Completion: 2019-12-30
• Study Completion: 2020-05-20
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 765

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Shwegyin	Drug resistance molecular markers	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.
Pinlebu	Drug resistance molecular markers	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.

Primary Outcome Measures

Name	Time	Method
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)
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.

Trial Locations

Locations (1)

Dr. Myat Phone Kyaw; 🇲🇲 Yangon, Myanmar