ClinicalTrials.gg
CompletedNCT04478578SEACTN-WP-AUpdated Oct 1, 2026

Incidences, Causes, and Outcomes of Febrile Illness in Rural South and Southeast Asia

An observational study in Febrile Illness, sponsored by University of Oxford. Completed at 7 sites in 5 countries. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by University of Oxford · Observational

Updated Oct 1, 2026Now CompletedResults publication added+5 moreGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
82,760
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Febrile Illness

Keywords

  • Febrile Illness
  • Incidence
  • Causes
  • Outcomes
03

In context

Lead sponsor

University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with an acute febrile illness of all ages presenting to village health workers (VHWs) or peripheral health facilities.

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

  • Documented fever (≥ 37.5°C axillary), hypothermia (\< 35.5°C) and/or history of fever in the last 24 hours.
  • Willingness and ability to comply with study protocol for the study duration.
  • Written given to participate in the trial.

Exclusion criteria

Exclusion Criteria:

  • Currently enrolled in the study
  • Accident or trauma is the cause for presentation
  • Presentation ≤ 3 days after routine immunisations
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

Observational model
Case-only
Time perspective
Prospective
Enrollment
82,760 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patients with febrile illness

    Participants from approximately 650 villages, with a target number of 100,000 episodes of febrile illness, will be enrolled into this study.

06

What researchers measure

Primary outcomes

  1. Local incidence of febrile illness

    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.

    Time frame: From Months 0 to 24

  2. Overall incidence of febrile illness

    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.

    Time frame: From Months 0 to 24

  3. Mortality

    Case fatality rates in febrile illness

    Time frame: Within approximately 1 month of first presentation to the village health worker or health facility

  4. Morbidity

    Duration of illness in patients presenting with a fever to the village health worker or health facility.

    Time frame: Over 1 month after first presentation

Secondary outcomes

  1. Prevalence of pathogens in febrile patients

    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.

    Time frame: Samples collected over approximately 24 months

  2. The correlation between host biomarker concentrations, aetiological diagnoses and clinical outcomes.

    The area under the curve, sensitivity and specificity of host biomarkers to identify bacterial infections and to predict severe outcomes.

    Time frame: Samples collected over approximately 24 months

07

Study locations

7 sites
  • Building Resources Across Communities (BRAC)
    Dhaka, 1212, Bangladesh
  • Medical Action Myanmar (MAM)
    Yangon, 11201, Burma
  • Action for Health Development (AHEAD)
    Battambang, Cambodia
  • Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU)
    Vientiane, Vientiane Prefecture 01000, Laos
  • Mahidol VivaResearch Unit, Faculty of Tropical Medicine, Mahidol University (MVRU)
    Ratchathewi, Bangkok 10400, Thailand
  • Shoklo Malaria Research Unit (SMRU)
    Mae Sot, Changwat Tak 63110, Thailand
  • Chiangrai Clinical Research Unit (CCRU)
    Chiang Rai, 57000, Thailand
08

References and documents

Publications

  • Chandna A, Chew R, Shwe Nwe Htun N, Peto TJ, Zhang M, Liverani M, Brummaier T, Phommasone K, Perrone C, Pyae Phyo A, Sattabongkot J, Roobsoong W, Nguitragool W, Sen A, Ibna Zaman S, Sandar Zaw A, Batty E, Waithira N, Abdad MY, Blacksell SD, Bodhidatta L, Callery JJ, Fagnark W, Huangsuranun W, Islam S, Lertcharoenchoke S, Lohavittayavikant S, Mukaka M, Moul V, Kumer Neogi A, Nedsuwan S, Pongvongsa T, Ponsap P, Richard-Greenblatt M, Schilling WHK, Thaipadungpanit J, Tripura R, Dondorp AM, Mayxay M, White NJ, Nosten F, Smithuis F, Ashley EA, Maude RJ, Day NPJ, Lubell Y. Defining the burden of febrile illness in rural South and Southeast Asia: an open letter to announce the launch of the Rural Febrile Illness project. Wellcome Open Res. 2022 Mar 10;6:64. doi: 10.12688/wellcomeopenres.16393.2. eCollection 2021. PubMed 34017924 ↗

Individual participant data

Plan to share: Yes — 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.

Time frame: After completion of trial activities and reporting

Access criteria: MORU Data Sharing Policy. (http://www.tropmedres.ac/data-sharing-policy)

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Completed
changed Oct 1, 2026
Sites
1 site added, 1 site removed
Show site
  • Shoklo Malaria Research Unit (SMRU) · Mae Sot, Thailand
Show 1 removed
  • Shoklo Malaria Research Unit (SMRU) · Mae Sot, Thailand
Oct 1, 2026
Primary completion
Dec 1, 2024→Dec 30, 2023 (actual)
Oct 1, 2026
Study completion
Dec 30, 2024→Dec 30, 2023 (actual)
Oct 1, 2026
Enrollment
100000 (estimated)→82760 (actual)
Oct 1, 2026
Publications
Results publication added: Chandna A, Chew R, Shwe Nwe Htun N, Peto TJ, Zhang M, Liverani M, Brummaier T, Phommasone K, Perrone C, Pyae Phyo A, Sattabongkot J, Roobsoong W, Nguitragool W… PubMed 34017924 ↗
Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    Recruiting→Completed
    Publications Results publication added: Chandna A, Chew R, Shwe Nwe Htun N, Peto TJ, Zhang M, Liverani M, Brummaier T, Phommasone K, Perrone C, Pyae Phyo A, Sattabongkot J, Roobsoong W, Nguitragool W… PubMed 34017924 ↗
    1 site added, 1 site removed
    Show site
    • Shoklo Malaria Research Unit (SMRU) · Mae Sot, Thailand
    Show 1 removed
    • Shoklo Malaria Research Unit (SMRU) · Mae Sot, Thailand
    Primary completion Dec 1, 2024→Dec 30, 2023 (now actual)
    Study completion Dec 30, 2024→Dec 30, 2023 (now actual)
    Enrollment 100000 (estimated)→82760 (actual)
    + 4 other changes: index terms, verification date, description and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04478578
Collaborators
Medical Action Myanmar, Shoklo Malaria Research Unit, Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit, Building Resources Across Communities (BRAC), Bangladesh, Mahidol Oxford Tropical Medicine Research Unit, Action for Health Development (AHEAD)
Responsible party
Sponsor
First posted
Jul 20, 2020
Start date
Aug 4, 2021
Primary completion
Dec 30, 2023
Completion
Dec 30, 2023
Last update
Oct 1, 2026

Study contacts

Yoel Lubell, Prof
principal investigator · Mahidol Oxford Tropical Medicine Research Unit

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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