Drug Resistance Among Asymptomatic Infection

Asymptomatic Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03648411
• Other study ID #: DMR_2018-108
• Status: Completed
• Start date: January 12, 2019
• Est. completion date: May 20, 2020

Study information

• Verified date: July 2020
• Source: Department of Medical Research, Lower Myanmar
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 765
• Est. completion date: May 20, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asymptomatic Infections
• Communicable Diseases
• Drug Resistant Malaria
• Infection
• Malaria
• Migrant Workers

Intervention

Genetic:
• Drug resistance molecular markers
Proportion of the drug resistance molecular markers will be found-out and compared.

Locations

Country	Name	City	State
Myanmar	Dr. Myat Phone Kyaw	Yangon

Sponsors (2)

Lead Sponsor	Collaborator
Department of Medical Research, Lower Myanmar	National Malaria Control Program, Myanmar

Country where clinical trial is conducted

Myanmar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of the asymptomatic infection among the study population	Number of the hidden malaria cases by RDT, microscopy or nested PCR (molecular method)	1 week
Primary	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.	3 months