Molecular Assessment of Drug Resistance Markers in Asymptomatic Malaria Cases and Malaria Antibody Kinetic

Malaria Clinical Trial

Official title:

Molecular Assessment of Drug Resistance Markers in Asymptomatic Malaria Cases in Myanmar Artemisinin Resistance Containment Zones and Malaria Antibody Kinetic Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02708199
• Other study ID #: KMRL_01_2016
• Status: Completed
• Phase: N/A
• First received: March 5, 2016
• Last updated: March 9, 2016
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Department of Medical Research, Lower Myanmar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Myanmar: Ethical Review Committee
• Study type: Observational

Clinical Trial Summary

Detection of the drug resistance molecular markers for falciparum and vivax in Longitudinal follow-up samples collected in Shwegyin Township, Bago Region that is Artemisinin Resistance Containment Tier I.

Description:

This study is longitudinal and observational cohort study to detect the drug resistance molecular markers in asymptomatic malaria infected local residents in study site. Only local residence who are not migrants, are recruited in the study and active and passive surveillance have been carried out within one year observation period. At the time of enrollment, blood film examination, rapid diagnosis test (RDT) testing have been done all together with the collection of the venous blood (about 1-2 mL) that would be used for molecular analysis later. All of the RDT or microscopy positive cases were treated according to the National Malaria Treatment Policy in Myanmar. A total of at least 1000 participants have been recruited in the study. Active case detection has been done in every three months. The venous blood were used for molecular based detection of the asymptomatic malaria infection by using High-throughout pooling strategy. All of the positive samples, (falciparum and vivax), have been checked for drug resistance molecular analaysis compared with the previously collected symptomatic malaria infection cases in the same region.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1179
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

• Local resident in stud sites

• Who give informed consent

• No known tentative plan to move/ migrant elsewhere within one year

Exclusion Criteria:

• Migrant or mobile population

• Less than 6 year

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asymptomatic Infection
• Asymptomatic Infections
• Increased Drug Resistance
• Malaria

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Department of Medical Research, Lower Myanmar	Kangwon National University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of the Asymptomatic malaria infection	Number of the asymptomatic malaria infection by molecular method in the sample collected from apparently healthy individuals. It have been done by nested PCR based method. Number of the asymptomatic infection will be finished in March 2016. (up to up to 5 months after last samples collection)	2016 March	No
Secondary	Number of the cases that showed drug resistance molecular markers in asymptomatic malaria infection	K13, Pffd, Pfmdr2 and Pfcrt markers for falciparum and Pvcrt-O, Pvdhps, Pvdhfr and Pvmdr1 for vivax asymptomatic infections.The target sequences will be analysed to detect the specific single nucleotide polymorphism (SNPs). Molecular marker analysis will be done as soon as after asymptomatic infection have been confirmed. It will be finished in 2016 April. (up to 6 months after last sample collection)	2016 April	No
Secondary	Prevalence of the different Malaria Antibody in local resident in Myanmar	Malaria antibody that against the malaria parasites will be assessed by using high sensitive protein microarray. Total overall prevalence will be assessed and time to time change of the antibody status will be observed. It will be started in April until December 2016.(Up to 14 months after last sample collection)	2016 December	No