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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04478578
Other study ID # BAC20001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 4, 2021
Est. completion date December 30, 2024

Study information

Verified date May 2024
Source University of Oxford
Contact Yoel Lubell, Prof.
Phone +66-857201350
Email yoel@tropmedres.ac
Is FDA regulated No
Health authority
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 December 30, 2024
Est. primary completion date December 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

Study Design


Related Conditions & MeSH terms


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
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