NCT02198573

Brief Summary

  • Artemisinin resistance have been documented in Myanmar and Myanmar artemisinin resistance containment measures have been launched since 2009-2010.
  • It is important to monitor the spread and magnitude of artemisinin resistant malaria in Myanmar.
  • So, day-3 surveillance study have been conducted.
  • Recently artemisinin resistant molecular marker, K13 have been identified and it was used as a tool in this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2014

Completed
Last Updated

July 23, 2014

Status Verified

July 1, 2014

Enrollment Period

5 months

First QC Date

July 22, 2014

Last Update Submit

July 22, 2014

Conditions

Day-3 Positive of ParasitaemiaPrevalence of Drug Resistance Gene Mutation

Keywords

malariaK13pfmrp1Myanmar

Outcome Measures

Primary Outcomes (1)

  • day-3 parasite positivity

    All of the enrolled patients were monitored with appropriate care up to third day and take the samples on day-3.

    3 days

Secondary Outcomes (1)

  • Prevalence of the drug resistance marker

    up to day-3

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All of the malaria suspected cases were invited to participated in this study from Myanmar-Thailand border and Myanmar-Bangladesh border.

You may qualify if:

  • confirmed uncomplicated falciparum malaria patients.
  • age \>2 years
  • box sex
  • given informed consent

You may not qualify if:

  • severe malaria
  • did not give informed consent
  • others diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Myat Phone Kyaw

Yangon, Yangon, 11191, Burma

Location

Related Publications (6)

  • World Health Organization. World Malaria Report 2013. Geneva, Switzerland, 2013.

    BACKGROUND

  • World Health Organization. Global report on antimalarial efficacy and drug resistance: 2000-2010. Geneva, Switzerland: World Health Organization, 2010.

    BACKGROUND

  • Stepniewska K, Ashley E, Lee SJ, Anstey N, Barnes KI, Binh TQ, D'Alessandro U, Day NP, de Vries PJ, Dorsey G, Guthmann JP, Mayxay M, Newton PN, Olliaro P, Osorio L, Price RN, Rowland M, Smithuis F, Taylor WR, Nosten F, White NJ. In vivo parasitological measures of artemisinin susceptibility. J Infect Dis. 2010 Feb 15;201(4):570-9. doi: 10.1086/650301.

    PMID: 20085495BACKGROUND

  • Ariey F, Witkowski B, Amaratunga C, Beghain J, Langlois AC, Khim N, Kim S, Duru V, Bouchier C, Ma L, Lim P, Leang R, Duong S, Sreng S, Suon S, Chuor CM, Bout DM, Menard S, Rogers WO, Genton B, Fandeur T, Miotto O, Ringwald P, Le Bras J, Berry A, Barale JC, Fairhurst RM, Benoit-Vical F, Mercereau-Puijalon O, Menard D. A molecular marker of artemisinin-resistant Plasmodium falciparum malaria. Nature. 2014 Jan 2;505(7481):50-5. doi: 10.1038/nature12876. Epub 2013 Dec 18.

    PMID: 24352242BACKGROUND

  • Singh B, Bobogare A, Cox-Singh J, Snounou G, Abdullah MS, Rahman HA. A genus- and species-specific nested polymerase chain reaction malaria detection assay for epidemiologic studies. Am J Trop Med Hyg. 1999 Apr;60(4):687-92. doi: 10.4269/ajtmh.1999.60.687.

    PMID: 10348249BACKGROUND

  • Kyaw MP, Nyunt MH, Chit K, Aye MM, Aye KH, Aye MM, Lindegardh N, Tarning J, Imwong M, Jacob CG, Rasmussen C, Perin J, Ringwald P, Nyunt MM. Reduced susceptibility of Plasmodium falciparum to artesunate in southern Myanmar. PLoS One. 2013;8(3):e57689. doi: 10.1371/journal.pone.0057689. Epub 2013 Mar 8.

    PMID: 23520478RESULT

Biospecimen

Retention: SAMPLES WITH DNA

dried blood spot

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Myat P Kyaw, PhD

    Department of Medical Research, Lower Myanmar

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Myat Htut Nyunt

Study Record Dates

First Submitted

July 22, 2014

First Posted

July 23, 2014

Study Start

July 1, 2013

Primary Completion

December 1, 2013

Study Completion

June 1, 2014

Last Updated

July 23, 2014

Record last verified: 2014-07

Locations

BU(1)