Incidences, Causes, and Outcomes of Febrile Illness in Rural South and Southeast Asia (SEACTN-WP-A)

June 8, 2023 updated by: University of Oxford

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).

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

100000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1212
        • Recruiting
        • Building Resources Across Communities (BRAC)
        • Contact:
        • Contact:
  • Cambodia
      • Battambang, Cambodia
        • Recruiting
        • Action for Health Development (AHEAD)
        • Contact:
        • Contact:
  • Lao People's Democratic Republic
    • Vientiane Prefecture
      • Vientiane, Vientiane Prefecture, Lao People's Democratic Republic, 01000
        • Recruiting
        • Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU)
        • Contact:
        • Contact:
  • Myanmar
      • Yangon, Myanmar, 11201
  • Thailand
      • Chiang Rai, Thailand, 57000
        • Recruiting
        • Chiangrai Clinical Research Unit (CCRU)
        • Contact:
        • Contact:
    • Bangkok
      • Ratchathewi, Bangkok, Thailand, 10400
        • Recruiting
        • Mahidol VivaResearch Unit, Faculty of Tropical Medicine, Mahidol University (MVRU)
        • Contact:
        • Contact:
    • Tak
      • Mae Sot, Tak, Thailand, 63110
        • Recruiting
        • Shoklo Malaria Research Unit (SMRU)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of pathogens in febrile patients
Time Frame: 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.
Samples collected over approximately 24 months
The correlation between host biomarker concentrations, aetiological diagnoses and clinical outcomes.
Time Frame: 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.
Samples collected over approximately 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

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

Investigators

  • Principal Investigator: Yoel Lubell, Prof, Mahidol Oxford Tropical Medicine Research Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2021

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

July 9, 2020

First Submitted That Met QC Criteria

July 15, 2020

First Posted (Actual)

July 20, 2020

Study Record Updates

Last Update Posted (Actual)

June 9, 2023

Last Update Submitted That Met QC Criteria

June 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAC20001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data collected for this study will be under the custodianship of MORU. With participant's consent, data from this study may be shared in a de-identified form with other groups or researchers in accordance with the MORU Data Sharing Policy.

IPD Sharing Time Frame

After completion of trial activities and reporting

IPD Sharing Access Criteria

MORU Data Sharing Policy. (http://www.tropmedres.ac/data-sharing-policy)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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