Febrile IllnessSEACTN-WP-ANCT04478578
Incidences, Causes, and Outcomes of Febrile Illness in Rural South and Southeast Asia
An observational study of Febrile Illness, run by University of Oxford at 7 sites in 5 countries.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Febrile Illness
- How many people
- 82,760 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 4 Aug 2021to 30 Dec 2023
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with an acute febrile illness of all ages presenting to village health workers (VHWs) or peripheral health facilities.
Who may be able to join
- 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 informed consent given to participate in the trial.
Who cannot join
- Currently enrolled in the study
- Accident or trauma is the cause for presentation
- Presentation ≤ 3 days after routine immunisations
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
Thailand3 sites
Chiangrai Clinical Research Unit (CCRU)
Chiang Rai, 57000
Shoklo Malaria Research Unit (SMRU)
Mae Sot, Changwat Tak, 63110
Mahidol VivaResearch Unit, Faculty of Tropical Medicine, Mahidol University (MVRU)
Ratchathewi, Bangkok, 10400
Laos1 site
Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU)
Vientiane, Vientiane Prefecture, 01000
About this study
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).
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.
- Conditions
- Febrile Illness
- Keywords
- Febrile Illness, Incidence, Causes, Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Months 0 to 24
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.
Measured: From Months 0 to 24
Mortality
Case fatality rates in febrile illness
Measured: Within approximately 1 month of first presentation to the village health worker or health facility
Morbidity
Duration of illness in patients presenting with a fever to the village health worker or health facility.
Measured: Over 1 month after first presentation
Secondary outcomes (2)
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.
Measured: Samples collected over approximately 24 months
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.
Measured: Samples collected over approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start4 Aug 2021
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Febrile IllnessStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 82,760 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Yoel Lubell, Prof, Principal investigator, Mahidol Oxford Tropical Medicine Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478578
- Sponsor's protocol ID
- BAC20001
- Acronym
- SEACTN-WP-A
- Status last verified
- Sep 2026
- First submitted
- 9 Jul 2020
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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