NCT02708199

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,179

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
Last Updated

March 15, 2016

Status Verified

March 1, 2016

Enrollment Period

11 months

First QC Date

March 5, 2016

Last Update Submit

March 9, 2016

Conditions

Increased Drug ResistanceAsymptomatic InfectionMalaria

Keywords

Drug resistance malariaMyanmar Artemisinin Resistance Containment ZoneAsymptomatic malariaSerology

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Number of the cases that showed drug resistance molecular markers in asymptomatic malaria infection

    2016 April

  • Prevalence of the different Malaria Antibody in local resident in Myanmar

    2016 December

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Shwegyin Township, Bago Region, Myanmar Artemisinin resistance containment Zone I.

You may qualify if:

  • Local resident in stud sites
  • Who give informed consent
  • No known tentative plan to move/ migrant elsewhere within one year

You may not qualify if:

  • Migrant or mobile population
  • Less than 6 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples have been collected and DNA have been extracted and keep at -20 degree C until analysis. Sera were also separately keep at -80 degree C until analysis.

MeSH Terms

Conditions

Asymptomatic InfectionsMalaria

Condition Hierarchy (Ancestors)

InfectionsAsymptomatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsProtozoan InfectionsParasitic DiseasesMosquito-Borne DiseasesVector Borne Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

March 5, 2016

First Posted

March 15, 2016

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 15, 2016

Record last verified: 2016-03