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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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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

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.

Yoel Lubell, Prof. contact

+66-857201350

yoel@tropmedres.ac

Rusheng Chew, Dr. contact

chris@tropmedres.ac

4 sites in 3 countries

Thailand2 sites, 2 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

    Recruiting

Other trials in Thailand

Bangladesh1 site, 1 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

    Not yet recruiting

Other trials in Bangladesh

Laos1 site, 1 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

    Recruiting

Other trials in Laos

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.

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 groups in NCT04629053
Study groupRoleWhat they receive
Patients with an acute febrile illnessPatients 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted16 Nov 2020
  2. Study start21 Jun 2022
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

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)
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.

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