<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/NCT02991963</url>
  </required_header>
  <id_info>
    <org_study_id>EPI1601</org_study_id>
    <nct_id>NCT02991963</nct_id>
  </id_info>
  <brief_title>Epidemiology of Malaria in Ubon Ratchathani, Thailand</brief_title>
  <official_title>Epidemiology of Malaria in Ubon Ratchathani, Thailand: a Case-control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mahidol Oxford Tropical Medicine Research Unit</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oxford</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an observational study (case-control study) aiming to identify risk factors for&#xD;
      malaria infection in health centers or malaria posts or district hospitals in Buntharik&#xD;
      District and Nachalui District, Ubon Ratchathani Province, Thailand.&#xD;
&#xD;
      This study expects to recruit 330 cases (malaria positive) and 330 control (negative cases)&#xD;
      subject. One-to-one matching of cases (malaria positive) and controls (malaria negative) will&#xD;
      be done at each study site.&#xD;
&#xD;
      CASE (Malaria positive) subject will go through the following;&#xD;
&#xD;
        1. Enrollment visit (Day 0)&#xD;
&#xD;
           1.1 Blood collection of three dried blood spots, and malaria slide. In district&#xD;
           hospitals in individuals &gt;14 kg: additional 10ml venous blood will be collected.&#xD;
&#xD;
           1.2 A survey questionnaire which includes patient demographics, information on malaria&#xD;
           treatment, bed net use and possible risk factors for acquiring malaria, as well as&#xD;
           questions about their travel and usage of mobile phones will be administered.&#xD;
&#xD;
        2. Follow up visits (if fever plus Day 42 (+/-3))&#xD;
&#xD;
      2.1 Blood collection of three dried blood spots and malaria slide. In district hospitals:&#xD;
      additional 0.5ml venous blood will be collected.&#xD;
&#xD;
      2.2 Short survey questionnaire including questions on symptoms, travel and possible risk&#xD;
      behaviors since enrollment will be administered.&#xD;
&#xD;
      CONTROL (Malaria negative) subject will go through the following;&#xD;
&#xD;
        1. Enrollment visit (Day 0)&#xD;
&#xD;
           1.1 Blood collection to confirm negative malaria slide. In district hospitals:&#xD;
           additional 0.5ml venous blood will be collected.&#xD;
&#xD;
           1.2 A survey questionnaire including patient demographics, information on any recent&#xD;
           malaria treatment they may have taken, bed net use and possible risk factors for&#xD;
           acquiring malaria, as well as questions about their travel and usage of mobile phones&#xD;
           will be administered.&#xD;
&#xD;
        2. Follow up visit: No follow up visit&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study sites and enrollment:&#xD;
&#xD;
      Patients self-presenting to (1) health centres or(2) malaria posts or (3) district hospitals&#xD;
      in Buntharik District and Nachalui District, Ubon Ratchathani Province, Thailand and&#xD;
      requiring a diagnostic test for malaria as determined by the treating clinician will be&#xD;
      recruited. Those who are malaria positive will be candidate cases and those who are malaria&#xD;
      negative will be candidate controls.&#xD;
&#xD;
      One-to-one matching of cases and controls will be done at each study site. One control will&#xD;
      be matched to each case. The matching criteria will be the next malaria negative patient to&#xD;
      attend the study site of the same gender and age+/-5 years as an enrolled malaria positive&#xD;
      case.&#xD;
&#xD;
      Study procedure:&#xD;
&#xD;
      CASE (Malaria patient defined by positive RDT or blood smear)&#xD;
&#xD;
      Upon enrollment, the below study procedures will be followed;&#xD;
&#xD;
        1. Blood samples consisting of:&#xD;
&#xD;
             -  Three dried blood spots&#xD;
&#xD;
             -  A microscopy slide&#xD;
&#xD;
             -  In the district hospitals only, 10 ml of venous blood will be taken from the&#xD;
                positive for malaria patient.&#xD;
&#xD;
        2. A survey include patient demographics, information on malaria treatment, bed net use and&#xD;
           possible risk factors for acquiring malaria, as well as questions about their travel and&#xD;
           usage of mobile phone will be administered to each patient.&#xD;
&#xD;
      CONTROL (Non-malaria patient defined by negative RDT or blood smear)&#xD;
&#xD;
      Upon enrollment, for those negative for malaria, the below study procedures will be follows;&#xD;
&#xD;
        1. Blood samples consisting of:&#xD;
&#xD;
             -  Blood smear&#xD;
&#xD;
             -  In the district hospitals only, 0.5 ml of venous blood will also be collected.&#xD;
&#xD;
        2. A survey include patient demographics, information on malaria treatment, bed net use and&#xD;
           possible risk factors for acquiring malaria, as well as questions about their travel and&#xD;
           usage of mobile phone swill be administered to each patient.&#xD;
&#xD;
      CASE: Follow-up&#xD;
&#xD;
        -  If patients develop a fever after the end of antimalarial treatment and within 42 days&#xD;
           after enrollment, they will be asked to return for follow-up as soon as possible on one&#xD;
           occasion and then again at 42 (+/-3) days.&#xD;
&#xD;
        -  If they do not develop fever within 42 days after enrollment, they will be asked to&#xD;
           return for follow up at 42 (+/-3) days.&#xD;
&#xD;
      At the follow-up visit, blood will be taken to test for malaria by microscopy, three dried&#xD;
      blood spots will be taken and a short survey administered including questions on symptoms,&#xD;
      travel and possible risk behaviors since enrollment.&#xD;
&#xD;
      *In the district hospitals only, 1.5ml of venous blood will be taken&#xD;
&#xD;
      CONTROL: No follow up&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Risk factors for Malaria infection</measure>
    <time_frame>2 years</time_frame>
    <description>Risk factors for malaria infection in Ubon Ratchathani Province, Thailand</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of malaria infections in Ubon Ratchathani Province</measure>
    <time_frame>2 years</time_frame>
    <description>Proportion of malaria infections that are imported in Ubon Ratchathani Province, Thailand</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of clinical antimalarial drug resistance</measure>
    <time_frame>2 years</time_frame>
    <description>Prevalence of clinical antimalarial drug resistance in cases of P. falciparum malaria in Ubon Ratchathani Province, Thailand</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Human movement leading to spread of malaria and antimalarial drug resistance</measure>
    <time_frame>2 years</time_frame>
    <description>4. Estimates of the potential for spread of malaria and antimalarial drug resistance from Ubon Ratchathani Province, Thailand through human movement to other locations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure antimalarial drug in blood prior to participate in the study</measure>
    <time_frame>2 years</time_frame>
    <description>List of antimalarials which patients have recently taken, if any, prior to presentation in order to estimate drug pressure on the parasite population.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">660</enrollment>
  <condition>Epidemiology</condition>
  <arm_group>
    <arm_group_label>Case</arm_group_label>
    <description>Malaria patient defined by positive RDT or blood smear</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Non-malaria patient defined by negative RDT or blood smear</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interview</intervention_name>
    <description>A survey will be included patient demographics, information on malaria treatment, bed net use and possible risk factors for acquiring malaria, as well as questions about their travel and usage of mobile phones</description>
    <arm_group_label>Case</arm_group_label>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood collection (Dried Blood Spot)</intervention_name>
    <description>Dried Blood Spot</description>
    <arm_group_label>Case</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood Collection (Venous Blood collection)</intervention_name>
    <description>Venous Blood collection</description>
    <arm_group_label>Case</arm_group_label>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood Smear</intervention_name>
    <description>Slide blood smear</description>
    <arm_group_label>Case</arm_group_label>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      1. Dried Blood Spot&#xD;
&#xD;
             -  To extract information on a broad variety of genetic variations.&#xD;
&#xD;
             -  To analyse for P. falciparum multi-drug resistance gene (MDR) copy number as a&#xD;
                marker of mefloquine resistance, as well as for merozoite surface protein (MSP),&#xD;
                glutamate rich protein (GLURP) and other markers to compare with follow-up samples&#xD;
                to identify relapses and recrudescences.&#xD;
&#xD;
        2. Venous Blood for parasite culture and in vitro drug sensitivity, cryopreservation of&#xD;
           parasites, malaria immunological tests, antimalarial pharmacokinetics, ultrasensitive&#xD;
           Plasmodium PCR and whole genome sequencing&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients self-presenting to health centres or malaria posts or district hospitals in&#xD;
        Buntharik District and Nachalui District, Ubon Ratchathani Province, Thailand and requiring&#xD;
        a diagnostic test for malaria as determined by the treating clinician will be recruited.&#xD;
        Those who are malaria positive will be candidate cases and those who are malaria negative&#xD;
        will be candidate controls.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Case (Malaria patient defined by positive RDT or blood smear):&#xD;
&#xD;
          -  Patients of ≥ 6 months of age testing positive for malaria of any species as&#xD;
             determined by a positive rapid diagnostic test (RDT) or asexual stage parasites on a&#xD;
             smear of peripheral blood including individuals with more than one species of&#xD;
             Plasmodium.&#xD;
&#xD;
               -  Control (Non-malaria patient defined by negative RDT or blood smear):&#xD;
&#xD;
          -  Patients &gt; 6 months of age requiring a diagnostic test for malaria but testing&#xD;
             negative for malaria by rapid diagnostic test (RDT) or asexual stage parasites on a&#xD;
             smear of peripheral blood. Controls will be age and gender matched to individual cases&#xD;
             at each study site (details below).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Not willing to provide written informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Richard James Maude, MD</last_name>
    <phone>+66922871420</phone>
    <email>richard@tropmedres.ac</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Vilasinee Yuwaree, Bsc.Pharm</last_name>
    <phone>+66817017165</phone>
    <email>vilasinee@tropmedres.ac</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Buntharik Hospital</name>
      <address>
        <city>Ubon Ratchathani</city>
        <state>Ubon Rachatani</state>
        <zip>34230</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tanong Kamsri, Doctor</last_name>
      <email>drtanong@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Vilasinee Yuwaree</last_name>
      <phone>+66817017165</phone>
      <email>vilasinee@tropmedres.ac</email>
    </contact_backup>
    <investigator>
      <last_name>Tanong Kamsri, doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>January 19, 2017</last_update_submitted>
  <last_update_submitted_qc>January 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malaria</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>According to Mahidol-Oxford Tropical Medicine Research Unit policy</ipd_description>
  </patient_data>
  <!-- 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/NCT02991963
org study id: EPI1601
nct id: NCT02991963
lead sponsor: 
collaborator: 
has dmc: No
This is an observational study (case-control study) aiming to identify risk factors for
      malaria infection in health centers or malaria posts or district hospitals in Buntharik
      District and Nachalui District, Ubon Ratchathani Province, Thailand.

      This study expects to recruit 330 cases (malaria positive) and 330 control (negative cases)
      subject. One-to-one matching of cases (malaria positive) and controls (malaria negative) will
      be done at each study site.

      CASE (Malaria positive) subject will go through the following;

        1. Enrollment visit (Day 0)

           1.1 Blood collection of three dried blood spots, and malaria slide. In district
           hospitals in individuals >14 kg: additional 10ml venous blood will be collected.

           1.2 A survey questionnaire which includes patient demographics, information on malaria
           treatment, bed net use and possible risk factors for acquiring malaria, as well as
           questions about their travel and usage of mobile phones will be administered.

        2. Follow up visits (if fever plus Day 42 (+/-3))

      2.1 Blood collection of three dried blood spots and malaria slide. In district hospitals:
      additional 0.5ml venous blood will be collected.

      2.2 Short survey questionnaire including questions on symptoms, travel and possible risk
      behaviors since enrollment will be administered.

      CONTROL (Malaria negative) subject will go through the following;

        1. Enrollment visit (Day 0)

           1.1 Blood collection to confirm negative malaria slide. In district hospitals:
           additional 0.5ml venous blood will be collected.

           1.2 A survey questionnaire including patient demographics, information on any recent
           malaria treatment they may have taken, bed net use and possible risk factors for
           acquiring malaria, as well as questions about their travel and usage of mobile phones
           will be administered.

        2. Follow up visit: No follow up visit
Study sites and enrollment:

      Patients self-presenting to (1) health centres or(2) malaria posts or (3) district hospitals
      in Buntharik District and Nachalui District, Ubon Ratchathani Province, Thailand and
      requiring a diagnostic test for malaria as determined by the treating clinician will be
      recruited. Those who are malaria positive will be candidate cases and those who are malaria
      negative will be candidate controls.

      One-to-one matching of cases and controls will be done at each study site. One control will
      be matched to each case. The matching criteria will be the next malaria negative patient to
      attend the study site of the same gender and age+/-5 years as an enrolled malaria positive
      case.

      Study procedure:

      CASE (Malaria patient defined by positive RDT or blood smear)

      Upon enrollment, the below study procedures will be followed;

        1. Blood samples consisting of:

             -  Three dried blood spots

             -  A microscopy slide

             -  In the district hospitals only, 10 ml of venous blood will be taken from the
                positive for malaria patient.

        2. A survey include patient demographics, information on malaria treatment, bed net use and
           possible risk factors for acquiring malaria, as well as questions about their travel and
           usage of mobile phone will be administered to each patient.

      CONTROL (Non-malaria patient defined by negative RDT or blood smear)

      Upon enrollment, for those negative for malaria, the below study procedures will be follows;

        1. Blood samples consisting of:

             -  Blood smear

             -  In the district hospitals only, 0.5 ml of venous blood will also be collected.

        2. A survey include patient demographics, information on malaria treatment, bed net use and
           possible risk factors for acquiring malaria, as well as questions about their travel and
           usage of mobile phone swill be administered to each patient.

      CASE: Follow-up

        -  If patients develop a fever after the end of antimalarial treatment and within 42 days
           after enrollment, they will be asked to return for follow-up as soon as possible on one
           occasion and then again at 42 (+/-3) days.

        -  If they do not develop fever within 42 days after enrollment, they will be asked to
           return for follow up at 42 (+/-3) days.

      At the follow-up visit, blood will be taken to test for malaria by microscopy, three dried
      blood spots will be taken and a short survey administered including questions on symptoms,
      travel and possible risk behaviors since enrollment.

      *In the district hospitals only, 1.5ml of venous blood will be taken

      CONTROL: No follow up
observational model: Case-Control
time perspective: Prospective
measure: Risk factors for Malaria infection
time frame: 2 years
description: Risk factors for malaria infection in Ubon Ratchathani Province, Thailand
measure: Proportion of malaria infections in Ubon Ratchathani Province
time frame: 2 years
description: Proportion of malaria infections that are imported in Ubon Ratchathani Province, Thailand
measure: Prevalence of clinical antimalarial drug resistance
time frame: 2 years
description: Prevalence of clinical antimalarial drug resistance in cases of P. falciparum malaria in Ubon Ratchathani Province, Thailand
measure: Human movement leading to spread of malaria and antimalarial drug resistance
time frame: 2 years
description: 4. Estimates of the potential for spread of malaria and antimalarial drug resistance from Ubon Ratchathani Province, Thailand through human movement to other locations.
measure: Measure antimalarial drug in blood prior to participate in the study
time frame: 2 years
description: List of antimalarials which patients have recently taken, if any, prior to presentation in order to estimate drug pressure on the parasite population.
arm group label: Case
description: Malaria patient defined by positive RDT or blood smear
arm group label: Control
description: Non-malaria patient defined by negative RDT or blood smear
intervention type: Other
intervention name: Interview
description: A survey will be included patient demographics, information on malaria treatment, bed net use and possible risk factors for acquiring malaria, as well as questions about their travel and usage of mobile phones
arm group label: Case
arm group label: Control
intervention type: Other
intervention name: Blood collection (Dried Blood Spot)
description: Dried Blood Spot
arm group label: Case
intervention type: Other
intervention name: Blood Collection (Venous Blood collection)
description: Venous Blood collection
arm group label: Case
arm group label: Control
intervention type: Other
intervention name: Blood Smear
description: Slide blood smear
arm group label: Case
arm group label: Control
1. Dried Blood Spot

             -  To extract information on a broad variety of genetic variations.

             -  To analyse for P. falciparum multi-drug resistance gene (MDR) copy number as a
                marker of mefloquine resistance, as well as for merozoite surface protein (MSP),
                glutamate rich protein (GLURP) and other markers to compare with follow-up samples
                to identify relapses and recrudescences.

        2. Venous Blood for parasite culture and in vitro drug sensitivity, cryopreservation of
           parasites, malaria immunological tests, antimalarial pharmacokinetics, ultrasensitive
           Plasmodium PCR and whole genome sequencing
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Months
maximum age: N/A
healthy volunteers: No
last name: Richard James Maude, MD
phone: +66922871420
email: richard@tropmedres.ac
last name: Vilasinee Yuwaree, Bsc.Pharm
phone: +66817017165
email: vilasinee@tropmedres.ac
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Thailand
responsible party type: Sponsor
mesh term: Malaria
sharing ipd: Yes
ipd description: According to Mahidol-Oxford Tropical Medicine Research Unit policy