Clinical trial NCT04478578: Incidences, Causes, and Outcomes of Febrile Illness in Rural South and Southeast Asia
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).
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Febrile Illness
Keywords: Febrile Illness
Incidence
Causes
Outcomes
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Medical Action Myanmar
name: Shoklo Malaria Research Unit
name: Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit
name: Building Resources Across Communities (BRAC), Bangladesh
name: Mahidol Oxford Tropical Medicine Research Unit
name: Action for Health Development (AHEAD)
First posted: 2020-07-20
Enrollment: 100000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an acute febrile illness of all ages presenting to village health workers (VHWs) or peripheral health facilities.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Local incidence of febrile illness
timeFrame: From Months 0 to 24
measure: Overall incidence of febrile illness
timeFrame: From Months 0 to 24
measure: Mortality
timeFrame: Within approximately 1 month of first presentation to the village health worker or health facility
measure: Morbidity
timeFrame: Over 1 month after first presentation
Secondary outcomes:
measure: Prevalence of pathogens in febrile patients
timeFrame: Samples collected over approximately 24 months
measure: The correlation between host biomarker concentrations, aetiological diagnoses and clinical outcomes.
timeFrame: Samples collected over approximately 24 months
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Building Resources Across Communities (BRAC)
city: Battambang
country: Cambodia
facility: Action for Health Development (AHEAD)
city: Vientiane
country: Lao People's Democratic Republic
facility: Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU)
state: Vientiane Prefecture
city: Yangon
country: Myanmar
facility: Medical Action Myanmar (MAM)
city: Ratchathewi
country: Thailand
facility: Mahidol VivaResearch Unit, Faculty of Tropical Medicine, Mahidol University (MVRU)
state: Bangkok
city: Mae Sot
country: Thailand
facility: Shoklo Malaria Research Unit (SMRU)
state: Tak
city: Chiang Rai
country: Thailand
facility: Chiangrai Clinical Research Unit (CCRU)
Study officials:
affiliation: Mahidol Oxford Tropical Medicine Research Unit
name: Yoel Lubell, Prof
role: PRINCIPAL_INVESTIGATOR
References: