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

NCT ID: NCT04478578

Last Updated: 2024-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-04

Study Completion Date

2024-12-30

Brief Summary

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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

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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.

Conditions

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Febrile Illness

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with febrile illness

Participants from approximately 650 villages, with a target number of 100,000 episodes of febrile illness, will be enrolled into this study.

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical Action Myanmar

OTHER

Sponsor Role collaborator

Shoklo Malaria Research Unit

OTHER

Sponsor Role collaborator

Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit

OTHER

Sponsor Role collaborator

Building Resources Across Communities (BRAC), Bangladesh

UNKNOWN

Sponsor Role collaborator

Mahidol Oxford Tropical Medicine Research Unit

OTHER

Sponsor Role collaborator

Action for Health Development (AHEAD)

UNKNOWN

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yoel Lubell, Prof

Role: PRINCIPAL_INVESTIGATOR

Mahidol Oxford Tropical Medicine Research Unit

Locations

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Building Resources Across Communities (BRAC)

Dhaka, , Bangladesh

Site Status RECRUITING

Medical Action Myanmar (MAM)

Yangon, , Burma

Site Status NOT_YET_RECRUITING

Action for Health Development (AHEAD)

Battambang, , Cambodia

Site Status RECRUITING

Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU)

Vientiane, Vientiane Prefecture, Laos

Site Status RECRUITING

Mahidol VivaResearch Unit, Faculty of Tropical Medicine, Mahidol University (MVRU)

Ratchathewi, Bangkok, Thailand

Site Status RECRUITING

Shoklo Malaria Research Unit (SMRU)

Mae Sot, Changwat Tak, Thailand

Site Status RECRUITING

Chiangrai Clinical Research Unit (CCRU)

Chiang Rai, , Thailand

Site Status RECRUITING

Countries

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Bangladesh Burma Cambodia Laos Thailand

Central Contacts

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Yoel Lubell, Prof.

Role: CONTACT

+66-857201350

Facility Contacts

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Aninda Sen, MBBS | MPH

Role: primary

(+880) 171 131 9050

Amit Neogi, Masters

Role: backup

(+880) 179 220 5401

Aye Sandar Zaw, MSc

Role: primary

(+95) 95133262

Htet Htet Aung, BA

Role: backup

(+95) 9421108636

Vanna Moul, MD

Role: primary

(+85) 553 900 898

Thomas Peto, PhD

Role: backup

(+66) 802 187 460

Koukeo Phommasone, PhD

Role: primary

+(85) 620 558 42842

Elizabeth Ashley, Prof.

Role: backup

(+85) 621 250 752

Wanlapa Roobsoong, Ph.D

Role: primary

(+66) 632 137 409

Dr. Jetsumon Prachumsri

Role: backup

+66 (0) 2306 9187

Aung Pyae Phyo, DPhil

Role: primary

055 532 026

Carlo Perrone, MD

Role: primary

(+66) 985 340 823

Nidanuch Tasak, Bachelor

Role: backup

(+66) 910 719 036

Other Identifiers

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BAC20001

Identifier Type: -

Identifier Source: org_study_id

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