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CompletedNCT02198573Updated Jul 23, 2014

Molecular Assessment of Artemisinin Resistance Markers in Eastern and Western Border Areas of Myanmar

An observational study in Day-3 Positive of Parasitaemia and Prevalence of Drug Resistance Gene Mutation, sponsored by Myat Htut Nyunt. Completed at 1 site in Myanmar. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2014-07-23.

Sponsored by Myat Htut Nyunt · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
91
Ages
2 Years and older
Sex
All
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Study 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.
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Conditions studied

  • Day-3 Positive of Parasitaemia
  • Prevalence of Drug Resistance Gene Mutation

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Keywords

  • malaria
  • K13
  • pfmrp1
  • Myanmar
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In context

Malaria

1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.

This study's enrollment of 91 is below the median of 582 across 204 observational studies indexed under Malaria.

Browse Malaria studies →

Lead sponsor

This is the only study on the registry with Myat Htut Nyunt as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • severe malaria
  • did not give
  • others diseases
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Time perspective
Prospective
Enrollment
91 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
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What researchers measure

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.

    Time frame: 3 days

Secondary outcomes

  1. Prevalence of the drug resistance marker

    By using the dried blood spots, drug resistance markers were detected by molecular method.

    Time frame: up to day-3

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Study locations

1 site
  • Dr. Myat Phone Kyaw
    Yangon, 11191, Myanmar
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References and documents

Publications

  • World Health Organization. World Malaria Report 2013. Geneva, Switzerland, 2013.
  • World Health Organization. Global report on antimalarial efficacy and drug resistance: 2000-2010. Geneva, Switzerland: World Health Organization, 2010.
  • 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. PubMed 20085495 ↗
  • 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. PubMed 24352242 ↗
  • 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. PubMed 10348249 ↗
  • 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. PubMed 23520478 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02198573
Lead sponsor
Myat Htut Nyunt
Collaborators
Kangwon National University
Responsible party
Myat Htut Nyunt (Dr. Myat Htut Nyunt, Department of Medical Research, Lower Myanmar) — Sponsor-investigator
First posted
Jul 23, 2014
Start date
Jul 2013
Primary completion
Dec 2013
Completion
Jun 2014
Last update
Jul 23, 2014

Study contacts

Myat P Kyaw, PhD
study director · Department of Medical Research, Lower Myanmar

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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