<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/NCT04478578</url>
  </required_header>
  <id_info>
    <org_study_id>BAC20001</org_study_id>
    <nct_id>NCT04478578</nct_id>
  </id_info>
  <brief_title>Incidences, Causes, and Outcomes of Febrile Illness in Rural South and Southeast Asia</brief_title>
  <acronym>SEACTN-WP-A</acronym>
  <official_title>Determining the Incidence, Causes and Outcomes of Rural Febrile Illness (RFI) in South and Southeast Asia, as Part of the South and Southeast Asian Community-based Trials Network (SEACTN). Work Package A (WP-A).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical Action Myanmar</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shoklo Malaria Research Unit</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Building Resources Across Communities (BRAC), Bangladesh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mahidol Oxford Tropical Medicine Research Unit</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Action for Health Development (AHEAD)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oxford</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will collect information to understand the causes and outcomes of febrile illness&#xD;
      in rural areas in countries across South and Southeast Asia ( including Cambodia, Laos,&#xD;
      Myanmar and Bangladesh). The findings will be used to identify new tests and treatments that&#xD;
      can improve the management of febrile patients in the future.&#xD;
&#xD;
      This study is funded by the UK Wellcome Trust. The grant reference number is 215604/Z/19/Z&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to better understand and quantify the burden of febrile illness, the&#xD;
      aetiological causes and the manner in which it affects the people living in rural areas in&#xD;
      South and Southeast Asia, all on a scale which has not been attempted before. The SEACTN RFI&#xD;
      project will collect information to help better understand and predict these outcomes based&#xD;
      on a multitude of factors, which will form the basis for interventions within the network in&#xD;
      the future. Determining the incidence, causes and outcomes of febrile illness in these&#xD;
      settings will be done through two work packages. The first of these, Work Package A (WP-A),&#xD;
      the subject of this study, will be carried out at the community level, primarily by engaging&#xD;
      village health worker (VHWs) and low-level Health Centres (HCs) which serve the communities&#xD;
      to recruit patients presenting with a febrile illness. These patients will be assessed for&#xD;
      presenting symptoms and followed up for clinical outcomes. Collection of specimen for&#xD;
      diagnostic investigations in these settings is challenging. Currently, mRDTs are conducted by&#xD;
      VHWs and HCs in these networks, therefore by using the same process, but also applying blood&#xD;
      to filter paper and allowing it to dry (DBS), investigators will test for certain other&#xD;
      pathogens, which will increase the aetiological yield.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 4, 2021</start_date>
  <completion_date type="Anticipated">April 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Local incidence of febrile illness</measure>
    <time_frame>From Months 0 to 24</time_frame>
    <description>The incidence per year that an individual seeks care for a febrile illness with the village health workers or local health facility, at the village level.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall incidence of febrile illness</measure>
    <time_frame>From Months 0 to 24</time_frame>
    <description>The incidence per year that an individual seeks care for a febrile illness with the village health workers or local health facility, at the regional level. These estimates will later be triangulated with and extrapolated from using health seeking behavior surveys for an estimate of the total incidence of febrile illness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>Within approximately 1 month of first presentation to the village health worker or health facility</time_frame>
    <description>Case fatality rates in febrile illness</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Morbidity</measure>
    <time_frame>Over 1 month after first presentation</time_frame>
    <description>Duration of illness in patients presenting with a fever to the village health worker or health facility.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of pathogens in febrile patients</measure>
    <time_frame>Samples collected over approximately 24 months</time_frame>
    <description>Pathogens will be detected in patients presenting over a 24 month period using point of care tests and diagnostic assays on acute and convalescent dried blood spots.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The correlation between host biomarker concentrations, aetiological diagnoses and clinical outcomes.</measure>
    <time_frame>Samples collected over approximately 24 months</time_frame>
    <description>The area under the curve, sensitivity and specificity of host biomarkers to identify bacterial infections and to predict severe outcomes.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100000</enrollment>
  <condition>Febrile Illness</condition>
  <arm_group>
    <arm_group_label>Patients with febrile illness</arm_group_label>
    <description>Participants from approximately 650 villages, with a target number of 100,000 episodes of febrile illness, will be enrolled into this study.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Dried blood spots (DBS)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with an acute febrile illness of all ages presenting to village health workers&#xD;
        (VHWs) or peripheral health facilities.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documented fever (≥ 37.5°C axillary), hypothermia (&lt; 35.5°C) and/or history of fever&#xD;
             in the last 24 hours.&#xD;
&#xD;
          -  Willingness and ability to comply with study protocol for the study duration.&#xD;
&#xD;
          -  Written informed consent given to participate in the trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently enrolled in the study&#xD;
&#xD;
          -  Accident or trauma is the cause for presentation&#xD;
&#xD;
          -  Presentation ≤ 3 days after routine immunisations&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yoel Lubell, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mahidol Oxford Tropical Medicine Research Unit</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yoel Lubell, Prof.</last_name>
    <phone>+66-857201350</phone>
    <email>yoel@tropmedres.ac</email>
  </overall_contact>
  <location>
    <facility>
      <name>Building Resources Across Communities (BRAC)</name>
      <address>
        <city>Dhaka</city>
        <zip>1212</zip>
        <country>Bangladesh</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aninda Sen, MBBS | MPH</last_name>
      <phone>(+880) 171 131 9050</phone>
      <email>aninda.sen@brac.net</email>
    </contact>
    <contact_backup>
      <last_name>Amit Neogi, Masters</last_name>
      <phone>(+880) 179 220 5401</phone>
      <email>amit.kn@brac.net</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Action for Health Development (AHEAD)</name>
      <address>
        <city>Battambang</city>
        <country>Cambodia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanna Moul, MD</last_name>
      <phone>(+85) 553 900 898</phone>
      <email>vanna@ahead.org.kh</email>
    </contact>
    <contact_backup>
      <last_name>Thomas Peto, PhD</last_name>
      <phone>(+66) 802 187 460</phone>
      <email>tom@tropmedres.ac</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU)</name>
      <address>
        <city>Vientiane</city>
        <state>Vientiane Prefecture</state>
        <zip>01000</zip>
        <country>Lao People's Democratic Republic</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Koukeo Phommasone, PhD</last_name>
      <phone>+(85) 620 558 42842</phone>
      <email>Koukeo@tropmedres.ac</email>
    </contact>
    <contact_backup>
      <last_name>Elizabeth Ashley, Prof.</last_name>
      <phone>(+85) 621 250 752</phone>
      <email>liz@tropmedres.ac</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Medical Action Myanmar (MAM)</name>
      <address>
        <city>Yangon</city>
        <zip>11201</zip>
        <country>Myanmar</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Aye Sandar Zaw, MSc</last_name>
      <phone>(+95) 95133262</phone>
      <email>ayesandarzaw@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Htet Htet Aung, BA</last_name>
      <phone>(+95) 9421108636</phone>
      <email>htethtetaung.mocru@gmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Mahidol VivaResearch Unit, Faculty of Tropical Medicine, Mahidol University (MVRU)</name>
      <address>
        <city>Ratchathewi</city>
        <state>Bangkok</state>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wanlapa Roobsoong, Ph.D</last_name>
      <phone>(+66) 632 137 409</phone>
      <email>wanlapa.ros@mahidol.edu</email>
    </contact>
    <contact_backup>
      <last_name>Dr. Jetsumon Prachumsri</last_name>
      <phone>+66 (0) 2306 9187</phone>
      <email>jetsumon.pra@mahidol.edu</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Shoklo Malaria Research Unit (SMRU)</name>
      <address>
        <city>Mae Sot</city>
        <state>Tak</state>
        <zip>63110</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aung Pyae Phyo, DPhil</last_name>
      <phone>055 532 026</phone>
      <email>aungpyaephyo@tropmedres.ac</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chiangrai Clinical Research Unit (CCRU)</name>
      <address>
        <city>Chiang Rai</city>
        <zip>57000</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carlo Perrone, MD</last_name>
      <phone>(+66) 985 340 823</phone>
      <email>Carlo@tropmedres.ac</email>
    </contact>
    <contact_backup>
      <last_name>Nidanuch Tasak, Bachelor</last_name>
      <phone>(+66) 910 719 036</phone>
      <email>nidanuch@tropmedres.ac</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Bangladesh</country>
    <country>Cambodia</country>
    <country>Lao People's Democratic Republic</country>
    <country>Myanmar</country>
    <country>Thailand</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>June 8, 2023</last_update_submitted>
  <last_update_submitted_qc>June 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Febrile Illness</keyword>
  <keyword>Incidence</keyword>
  <keyword>Causes</keyword>
  <keyword>Outcomes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperthermia</mesh_term>
    <mesh_term>Fever</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data collected for this study will be under the custodianship of MORU. With participant's consent, data from this study may be shared in a de-identified form with other groups or researchers in accordance with the MORU Data Sharing Policy.</ipd_description>
    <ipd_time_frame>After completion of trial activities and reporting</ipd_time_frame>
    <ipd_access_criteria>MORU Data Sharing Policy. (http://www.tropmedres.ac/data-sharing-policy)</ipd_access_criteria>
  </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/NCT04478578
org study id: BAC20001
nct id: NCT04478578
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will collect information to understand the causes and outcomes of febrile illness
      in rural areas in countries across South and Southeast Asia ( including Cambodia, Laos,
      Myanmar and Bangladesh). The findings will be used to identify new tests and treatments that
      can improve the management of febrile patients in the future.

      This study is funded by the UK Wellcome Trust. The grant reference number is 215604/Z/19/Z
This study aims to better understand and quantify the burden of febrile illness, the
      aetiological causes and the manner in which it affects the people living in rural areas in
      South and Southeast Asia, all on a scale which has not been attempted before. The SEACTN RFI
      project will collect information to help better understand and predict these outcomes based
      on a multitude of factors, which will form the basis for interventions within the network in
      the future. Determining the incidence, causes and outcomes of febrile illness in these
      settings will be done through two work packages. The first of these, Work Package A (WP-A),
      the subject of this study, will be carried out at the community level, primarily by engaging
      village health worker (VHWs) and low-level Health Centres (HCs) which serve the communities
      to recruit patients presenting with a febrile illness. These patients will be assessed for
      presenting symptoms and followed up for clinical outcomes. Collection of specimen for
      diagnostic investigations in these settings is challenging. Currently, mRDTs are conducted by
      VHWs and HCs in these networks, therefore by using the same process, but also applying blood
      to filter paper and allowing it to dry (DBS), investigators will test for certain other
      pathogens, which will increase the aetiological yield.
observational model: Case-Only
time perspective: Prospective
measure: Local incidence of febrile illness
time frame: From Months 0 to 24
description: The incidence per year that an individual seeks care for a febrile illness with the village health workers or local health facility, at the village level.
measure: Overall incidence of febrile illness
time frame: From Months 0 to 24
description: The incidence per year that an individual seeks care for a febrile illness with the village health workers or local health facility, at the regional level. These estimates will later be triangulated with and extrapolated from using health seeking behavior surveys for an estimate of the total incidence of febrile illness.
measure: Mortality
time frame: Within approximately 1 month of first presentation to the village health worker or health facility
description: Case fatality rates in febrile illness
measure: Morbidity
time frame: Over 1 month after first presentation
description: Duration of illness in patients presenting with a fever to the village health worker or health facility.
measure: Prevalence of pathogens in febrile patients
time frame: Samples collected over approximately 24 months
description: Pathogens will be detected in patients presenting over a 24 month period using point of care tests and diagnostic assays on acute and convalescent dried blood spots.
measure: The correlation between host biomarker concentrations, aetiological diagnoses and clinical outcomes.
time frame: Samples collected over approximately 24 months
description: The area under the curve, sensitivity and specificity of host biomarkers to identify bacterial infections and to predict severe outcomes.
arm group label: Patients with febrile illness
description: Participants from approximately 650 villages, with a target number of 100,000 episodes of febrile illness, will be enrolled into this study.
Dried blood spots (DBS)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Yoel Lubell, Prof
role: Principal Investigator
affiliation: Mahidol Oxford Tropical Medicine Research Unit
last name: Yoel Lubell, Prof.
phone: +66-857201350
email: yoel@tropmedres.ac
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: Bangladesh
country: Cambodia
country: Lao People's Democratic Republic
country: Myanmar
country: Thailand
responsible party type: Sponsor
mesh term: Hyperthermia
mesh term: Fever
sharing ipd: Yes
ipd description: Data collected for this study will be under the custodianship of MORU. With participant's consent, data from this study may be shared in a de-identified form with other groups or researchers in accordance with the MORU Data Sharing Policy.
ipd time frame: After completion of trial activities and reporting
ipd access criteria: MORU Data Sharing Policy. (http://www.tropmedres.ac/data-sharing-policy)