Causes and Outcomes of Febrile Illness in Health Facilities in Rural South and Southeast Asia
NCT ID: NCT04629053
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
7200 participants
OBSERVATIONAL
2022-06-21
2026-12-01
Brief Summary
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This study is funded by the UK Wellcome Trust. The grant reference number is 215604/Z/19/Z
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Detailed Description
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The South and Southeast Asian Community-based Trials Network in Rural Febrile Illness project (SEACTN RFI) aims to better understand and quantify the burden of febrile illness, the aetiological causes and the manner in which it affects the people of the area, all on a scale which has not been attempted before. It 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. The initial study will be observational, as the current understanding of the local health issues and the health systems in these areas is insufficient to know how best to intervene.
In a separate work package, Work Package A (WP-A), the investigators will be collecting data from within the participating SEACTN communities through village health workers (VHWs) and local health facilities on the incidence, causes and outcomes of febrile illness in these areas.
In Work Package B (WP-B) will recruit patients seeking care at higher level facilities than the WP-A VHWs and health centres. These patients are likely to be more severely ill, in order to obtain a more thorough understanding of the causes and burden of febrile illness in these areas. A broader range of specimens, including venous blood samples and respiratory specimens will be collected. In-depth diagnostic testing including blood cultures, serological assays, pathogen molecular diagnostics, host biomarker assays, and validation of pathogen-blind next generation sequencing approaches will be conducted. The data from WP-A gathered in the community complemented by the WP-B data from higher level health facilities in the same regions will provide a rich understanding of the causes, incidence and outcomes of febrile illness in these areas. These data will be analysed using advanced statistical methodology to create electronic decision-support tools (eDSTs) to aid VHWs in their assessment, triage and treatment of patients. These and other relevant interventions will later be trialled across the SEACTN villages.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients with an acute febrile illness
Patients with acute febrile illness, 4,800 children and 2,400 adults, divided equally across four countries (Laos, Myanmar,Thailand (including the Thai-Myanmar border region), and Bangladesh) and three age groups: \>28 days to \<5 years; ≥5 years to \<15 years, and ≥15 years of age.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Aged \> 28 days (day of birth = Day 1);
3. Axillary temperature at presentation (≥ 37.5°C (99.5°F) OR \< 35.5°C (95.9°F)) and no more likely cause than sepsis for hypothermia OR History of fever in the 24 hours prior to presentation;
4. Onset of illness ≤ 14 days
Exclusion Criteria
2. Presentation ≤ 3 days after routine immunisations
3. Is currently under follow-up or has been afebrile for less than 72 hours after completion of a follow-up period.
4. The treating healthcare worker's decision is to send the patient home following initial assessment.
29 Days
ALL
No
Sponsors
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Shoklo Malaria Research Unit (SMRU)
UNKNOWN
Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit
OTHER
Building Resources Across Communities (BRAC), Bangladesh
UNKNOWN
Mahidol Oxford Tropical Medicine Research Unit
OTHER
Chiang Rai Clinical Research Unit (CCRU), Thailand
UNKNOWN
University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Yoel Lubell, Prof.
Role: PRINCIPAL_INVESTIGATOR
Mahidol Oxford Tropical Medicine Research Unit
Locations
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Building Resources Across Communities (BRAC)
Dhaka, , Bangladesh
Laos-Oxford-Mahosot Wellcome Trust Research Unit
Vientiane, , Laos
Shoklo Malaria Research Unit
Mae Sot, Changwat Tak, Thailand
Chiangrai Clinical Research Unit (CCRU)
Chiang Rai, , Thailand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BAC20003
Identifier Type: -
Identifier Source: org_study_id
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