<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02198573</url>
  </required_header>
  <id_info>
    <org_study_id>WHO_3DF_2013_day3</org_study_id>
    <nct_id>NCT02198573</nct_id>
  </id_info>
  <brief_title>Molecular Assessment of Artemisinin Resistance Markers in Eastern and Western Border Areas of Myanmar</brief_title>
  <official_title>Molecular Assessment of Artemisinin Resistance Markers, K13 Kelch Propeller and Multi-drug Resistant Gene Polymorphism in Eastern and Western Border Areas of Myanmar</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Myat Htut Nyunt</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kangwon National University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Department of Medical Research, Lower Myanmar</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  Artemisinin resistance have been documented in Myanmar and Myanmar artemisinin&#xD;
           resistance containment measures have been launched since 2009-2010.&#xD;
&#xD;
        -  It is important to monitor the spread and magnitude of artemisinin resistant malaria in&#xD;
           Myanmar.&#xD;
&#xD;
        -  So, day-3 surveillance study have been conducted.&#xD;
&#xD;
        -  Recently artemisinin resistant molecular marker, K13 have been identified and it was&#xD;
           used as a tool in this study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>day-3 parasite positivity</measure>
    <time_frame>3 days</time_frame>
    <description>All of the enrolled patients were monitored with appropriate care up to third day and take the samples on day-3.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of the drug resistance marker</measure>
    <time_frame>up to day-3</time_frame>
    <description>By using the dried blood spots, drug resistance markers were detected by molecular method.</description>
  </secondary_outcome>
  <enrollment type="Actual">91</enrollment>
  <condition>Day-3 Positive of Parasitaemia</condition>
  <condition>Prevalence of Drug Resistance Gene Mutation</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      dried blood spot&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All of the malaria suspected cases were invited to participated in this study from&#xD;
        Myanmar-Thailand border and Myanmar-Bangladesh border.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  confirmed uncomplicated falciparum malaria patients.&#xD;
&#xD;
          -  age &gt;2 years&#xD;
&#xD;
          -  box sex&#xD;
&#xD;
          -  given informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe malaria&#xD;
&#xD;
          -  did not give informed consent&#xD;
&#xD;
          -  others diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Myat P Kyaw, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Department of Medical Research, Lower Myanmar</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dr. Myat Phone Kyaw</name>
      <address>
        <city>Yangon</city>
        <zip>11191</zip>
        <country>Myanmar</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Myanmar</country>
  </location_countries>
  <reference>
    <citation>World Health Organization. World Malaria Report 2013. Geneva, Switzerland, 2013.</citation>
  </reference>
  <reference>
    <citation>World Health Organization. Global report on antimalarial efficacy and drug resistance: 2000-2010. Geneva, Switzerland: World Health Organization, 2010.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>20085495</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24352242</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>10348249</PMID>
  </reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>23520478</PMID>
  </results_reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>July 22, 2014</last_update_submitted>
  <last_update_submitted_qc>July 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Department of Medical Research, Lower Myanmar</investigator_affiliation>
    <investigator_full_name>Myat Htut Nyunt</investigator_full_name>
    <investigator_title>Dr. Myat Htut Nyunt</investigator_title>
  </responsible_party>
  <keyword>malaria</keyword>
  <keyword>K13</keyword>
  <keyword>pfmrp1</keyword>
  <keyword>Myanmar</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parasitemia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02198573
org study id: WHO_3DF_2013_day3
nct id: NCT02198573
lead sponsor: 
collaborator: 
has dmc: Yes
-  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.
time perspective: Prospective
measure: day-3 parasite positivity
time frame: 3 days
description: All of the enrolled patients were monitored with appropriate care up to third day and take the samples on day-3.
measure: Prevalence of the drug resistance marker
time frame: up to day-3
description: By using the dried blood spots, drug resistance markers were detected by molecular method.
dried blood spot
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: N/A
healthy volunteers: No
last name: Myat P Kyaw, PhD
role: Study Director
affiliation: Department of Medical Research, Lower Myanmar
facility: 
country: Myanmar
citation: World Health Organization. World Malaria Report 2013. Geneva, Switzerland, 2013.
citation: World Health Organization. Global report on antimalarial efficacy and drug resistance: 2000-2010. Geneva, Switzerland: World Health Organization, 2010.
citation: 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: 20085495
citation: 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: 24352242
citation: 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: 10348249
citation: 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: 23520478
responsible party type: Sponsor-Investigator
investigator affiliation: Department of Medical Research, Lower Myanmar
investigator full name: Myat Htut Nyunt
investigator title: Dr. Myat Htut Nyunt
mesh term: Parasitemia