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

Recruiting

• Conditions: Febrile Illness

• Registration Number: NCT04478578
• Lead Sponsor: University of Oxford

Brief 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

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.

Study Timeline

• Study First Submitted: 2020-07-09
• Study First Submitted QC: 2020-07-15
• Study First Posted: 2020-07-20
• Study Start: 2021-08-04
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-09
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100000

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 informed consent given to participate in the trial.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Local incidence of febrile illness	From Months 0 to 24	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.
Overall incidence of febrile illness	From Months 0 to 24	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.
Mortality	Within approximately 1 month of first presentation to the village health worker or health facility	Case fatality rates in febrile illness
Morbidity	Over 1 month after first presentation	Duration of illness in patients presenting with a fever to the village health worker or health facility.

Secondary Outcome Measures

Name	Time	Method
The correlation between host biomarker concentrations, aetiological diagnoses and clinical outcomes.	Samples collected over approximately 24 months	The area under the curve, sensitivity and specificity of host biomarkers to identify bacterial infections and to predict severe outcomes.
Prevalence of pathogens in febrile patients	Samples collected over approximately 24 months	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.

Trial Locations

Locations (7)

Building Resources Across Communities (BRAC); 🇧🇩 Dhaka, Bangladesh

Action for Health Development (AHEAD); 🇰🇭 Battambang, Cambodia

Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU); 🇱🇦 Vientiane, Vientiane Prefecture, Lao People's Democratic Republic

Medical Action Myanmar (MAM); 🇲🇲 Yangon, Myanmar

Mahidol VivaResearch Unit, Faculty of Tropical Medicine, Mahidol University (MVRU); 🇹🇭 Ratchathewi, Bangkok, Thailand

Chiangrai Clinical Research Unit (CCRU); 🇹🇭 Chiang Rai, Thailand

Shoklo Malaria Research Unit (SMRU); 🇹🇭 Mae Sot, Tak, Thailand