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

Febrile Illness Clinical Trial

— SEACTN-WP-A  

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04478578
• Other study ID #: BAC20001
• Status: Recruiting
• Start date: August 4, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2023
• Source: University of Oxford
• Contact: Yoel Lubell, Prof.
• Phone: +66-857201350
• Email: yoel[@]tropmedres.ac
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: April 30, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Febrile Illness
• Fever
• Hyperthermia

Locations

Country	Name	City	State
Bangladesh	Building Resources Across Communities (BRAC)	Dhaka
Cambodia	Action for Health Development (AHEAD)	Battambang
Lao People's Democratic Republic	Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU)	Vientiane	Vientiane Prefecture
Myanmar	Medical Action Myanmar (MAM)	Yangon
Thailand	Chiangrai Clinical Research Unit (CCRU)	Chiang Rai
Thailand	Shoklo Malaria Research Unit (SMRU)	Mae Sot	Tak
Thailand	Mahidol VivaResearch Unit, Faculty of Tropical Medicine, Mahidol University (MVRU)	Ratchathewi	Bangkok

Sponsors (7)

Lead Sponsor	Collaborator
University of Oxford	Action for Health Development (AHEAD), Building Resources Across Communities (BRAC), Bangladesh, Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit, Mahidol Oxford Tropical Medicine Research Unit, Medical Action Myanmar, Shoklo Malaria Research Unit

Countries where clinical trial is conducted

Bangladesh,  Cambodia,  Lao People's Democratic Republic,  Myanmar,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From Months 0 to 24
Primary	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.	From Months 0 to 24
Primary	Mortality	Case fatality rates in febrile illness	Within approximately 1 month of first presentation to the village health worker or health facility
Primary	Morbidity	Duration of illness in patients presenting with a fever to the village health worker or health facility.	Over 1 month after first presentation
Secondary	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.	Samples collected over approximately 24 months
Secondary	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.	Samples collected over approximately 24 months