Acute Febrile IllnessSEACTN-WP-BNCT04629053
Causes and Outcomes of Febrile Illness in Health Facilities in Rural South and Southeast Asia
An observational study of Acute Febrile Illness, run by University of Oxford at 4 sites in 3 countries.
Trial summary
This prospective multi-site observational study aims to describe causes and clinical outcomes of acute febrile illness as well as host biomarkers in patients aged >28 days residing in rural areas in Laos, Myanmar, Thailand, the Thai-Myanmar border region, and Bangladesh and presenting with acute febrile illnesses (≤… Read more about this study
- Who is it for?
- Ages 29 days and older
- Conditions the study is for
- Acute Febrile Illness
- How many people
- 7,200 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 21 Jun 2022to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 29 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients residing in rural areas in Laos, Myanmar, Thailand, the Thai-Myanmar border region, and Bangladesh and presenting with acute febrile illnesses to participating health facilities
Who may be able to join
- The patient and/or where relevant their parent/guardian/caretaker is willing and able to give informed consent /assent for participation in the study;
- Aged > 28 days (day of birth = Day 1);
- 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;
- Onset of illness ≤ 14 days
Who cannot join
- Accident or trauma is the cause for the patient's presentation;
- Presentation ≤ 3 days after routine immunisations
- Is currently under follow-up or has been afebrile for less than 72 hours after completion of a follow-up period.
- The treating healthcare worker's decision is to send the patient home following initial assessment.
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Rusheng Chew, Dr. contact
4 sites in 3 countries
Thailand2 sites, 2 recruiting
- Recruiting
Chiangrai Clinical Research Unit (CCRU)
Chiang Rai, 57000
Carlo Perrone, MD, (+66) 985 340 823, Carlo@tropmedres.ac
Nidanuch Tasak, Bachelor, (+66)910 719 036, nidanuch@tropmedres.ac
- Recruiting
Shoklo Malaria Research Unit
Mae Sot, Changwat Tak, 63110
Aung Pyae Phyo, Dr, +66064292107, aungpyaephyo@tropmedres.ac
Francois Nosten, Professor, francois@tropmedres.ac
Bangladesh1 site, 1 recruiting
- Not yet recruiting
Building Resources Across Communities (BRAC)
Dhaka, 1212
Aninda Sen, MBBS | MPH, (+880) 171 131 9050, aninda.sen@brac.net
Amit Neogi, Masters, (+880)179 220 5401, amit.kn@brac.net
Laos1 site, 1 recruiting
- Recruiting
Laos-Oxford-Mahosot Wellcome Trust Research Unit
Vientiane, 01000
Koukeo Phommasone, PhD, +(85) 620 558 42842, Koukeo@tropmedres.ac
Elizabeth Ashley, Professor, (+85)621 250 752, liz@tropmedres.ac
About this study
Official title: Determining the Causes and Outcomes of Febrile Illness in Health Care Facilities in Rural South and Southeast Asia, as Part of the South and Southeast Asian Community-based Trials Network (SEACTN). Work Package B (WP-B).
This prospective multi-site observational study aims to describe causes and clinical outcomes of acute febrile illness as well as host biomarkers in patients aged >28 days residing in rural areas in Laos, Myanmar, Thailand, the Thai-Myanmar border region, and Bangladesh and presenting with acute febrile illnesses (≤ 14 days duration) to participating health facilities.
This study is funded by the UK Wellcome Trust. The grant reference number is 215604/Z/19/Z
Read the detailed description
The majority of people in low- and middle-income countries (LMICs) in South and Southeast Asia live in rural areas. These people are some of the poorest in the region and the exact health issues which concern them have not been well defined, in that they have not been fully studied. Despite this lack of data, there are indications that disease of an infectious aetiology, 'febrile illness,' in particular in the tropics, still accounts for significant morbidity and mortality. This is in contrast to higher-income countries.
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
- Acute Febrile Illness
- Keywords
- Acute Febrile Illness, 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 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of pathogens
Prevalence of a range of pathogens identified from febrile patients, analysed by region and participant age group
Measured: Samples collected over approximately 1 month
Secondary outcomes (2)
Recovery status
Recovery status e.g. full recovery, partial recovery, deterioration, and death at specified time points up to 28 days from enrolment
Measured: Approximately 1 month
The association between host biomarkers and other predictors with aetiological diagnoses and clinical outcomes
The area under the curve, sensitivity and specificity of host biomarkers and other predictors to identify bacterial infections and to predict severe outcomes.
Measured: Samples collected over approximately 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start21 Jun 2022
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- 7,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Shoklo Malaria Research Unit (SMRU), Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit, Building Resources Across Communities (BRAC), Bangladesh, Mahidol Oxford Tropical Medicine Research Unit, Chiang Rai Clinical Research Unit (CCRU), Thailand
- Responsible party
- Sponsor
- Investigators
- Yoel Lubell, Prof., Principal investigator, Mahidol Oxford Tropical Medicine Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629053
- Sponsor's protocol ID
- BAC20003
- Acronym
- SEACTN-WP-B
- Status last verified
- Jan 2026
- First submitted
- 9 Nov 2020
- Last updated
- 12 Jan 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Causes and Outcomes of Febrile Illness in Health Care Facilities in Rural South and Southeast Asia, as Part of the South and Southeast Asian Community-based Trials Network (SEACTN). Work Package B (WP-B).
- ClinicalTrials.gov ID
- NCT04629053
- Acronym / sponsor ID
- SEACTN-WP-B / BAC20003
- Conditions
- Acute Febrile Illness
- Keywords
- Acute Febrile Illness, Causes, Outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7,200 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Shoklo Malaria Research Unit (SMRU), Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit, Building Resources Across Communities (BRAC), Bangladesh, Mahidol Oxford Tropical Medicine Research Unit, Chiang Rai Clinical Research Unit (CCRU), Thailand
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective multi-site observational study aims to describe causes and clinical outcomes of acute febrile illness as well as host biomarkers in patients aged >28 days residing in rural areas in Laos, Myanmar, Thailand, the Thai-Myanmar border region, and Bangladesh and presenting with acute febrile illnesses (≤ 14 days duration) to participating health facilities.
This study is funded by the UK Wellcome Trust. The grant reference number is 215604/Z/19/Z
Detailed description
The majority of people in low- and middle-income countries (LMICs) in South and Southeast Asia live in rural areas. These people are some of the poorest in the region and the exact health issues which concern them have not been well defined, in that they have not been fully studied. Despite this lack of data, there are indications that disease of an infectious aetiology, 'febrile illness,' in particular in the tropics, still accounts for significant morbidity and mortality. This is in contrast to higher-income countries.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 29 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients residing in rural areas in Laos, Myanmar, Thailand, the Thai-Myanmar border region, and Bangladesh and presenting with acute febrile illnesses to participating health facilities
Key inclusion criteria (4 listed)
- The patient and/or where relevant their parent/guardian/caretaker is willing and able to give informed consent /assent for participation in the study;
- Aged > 28 days (day of birth = Day 1);
- 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;
- Onset of illness ≤ 14 days
Key exclusion criteria (4 listed)
- Accident or trauma is the cause for the patient's presentation;
- Presentation ≤ 3 days after routine immunisations
- Is currently under follow-up or has been afebrile for less than 72 hours after completion of a follow-up period.
- The treating healthcare worker's decision is to send the patient home following initial assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of pathogens
Time frame: Samples collected over approximately 1 month
Prevalence of a range of pathogens identified from febrile patients, analysed by region and participant age group
2 secondary outcomes
Recovery status
Time frame: Approximately 1 month
The association between host biomarkers and other predictors with aetiological diagnoses and clinical outcomes
Time frame: Samples collected over approximately 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rusheng Chew, Dr. contact
Yoel Lubell, Prof. principal investigator
Mahidol Oxford Tropical Medicine Research Unit
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Febrile Illness, run by University of Oxford at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Thailand, Bangladesh, Laos. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yoel Lubell, Prof. (+66-857201350, yoel@tropmedres.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of pathogens (time frame: Samples collected over approximately 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.