Causes and Outcomes of Febrile Illness in Health Facilities in Rural South and Southeast Asia

NCT04629053 | Recruiting

• 1 other identifier: BAC20003
• Study Type: observational
• Target: 7,200
• Locations: 3 countries
• Sites: 4

Brief 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 (≤ 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

Conditions

Acute Febrile Illness

Keywords

Acute Febrile Illness; Causes; Outcomes

Outcome Measures

Primary Outcomes (1)

• Prevalence of pathogens

  Prevalence of a range of pathogens identified from febrile patients, analysed by region and participant age group

  Samples collected over approximately 1 month

Secondary Outcomes (2)

• Recovery status

  Approximately 1 month

• The association between host biomarkers and other predictors with aetiological diagnoses and clinical outcomes

  Samples collected over approximately 1 month

Study Arms (1)

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.

Eligibility Criteria

• Age: 29 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Building Resources Across Communities (BRAC), Bangladesh: collaborator
• Mahidol Oxford Tropical Medicine Research Unit: collaborator
• Chiang Rai Clinical Research Unit (CCRU), Thailand: collaborator
• University of Oxford: lead
• Shoklo Malaria Research Unit (SMRU): collaborator
• Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit: collaborator

Study Sites (4)

Building Resources Across Communities (BRAC)

Dhaka, 1212, Bangladesh

NOT YET RECRUITING

Laos-Oxford-Mahosot Wellcome Trust Research Unit

Vientiane, 01000, Laos

RECRUITING

Shoklo Malaria Research Unit

Mae Sot, Changwat Tak, 63110, Thailand

RECRUITING

Chiangrai Clinical Research Unit (CCRU)

Chiang Rai, 57000, Thailand

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood samples and nasal swabs

Study Officials

• Yoel Lubell, Prof.

  Mahidol Oxford Tropical Medicine Research Unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoel Lubell, Prof.

CONTACT

+66-857201350; yoel@tropmedres.ac

Rusheng Chew, Dr.

CONTACT

chris@tropmedres.ac

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 16, 2020
• Study Start: June 21, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: After completion of trial activities and reporting
• Access Criteria: MORU Data Sharing Policy. (http://www.tropmedres.ac/data-sharing-policy)

Locations

TH (2); LA (1); BA (1)