Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04629053 |
Other study ID # |
BAC20003 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
June 21, 2022 |
Est. completion date |
December 1, 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
This prospective multi-site observational study aims to describe causes and clinical outcomes
of acute febrile illness as well as host biomarkers in patients aged >28 days residing in
rural areas in Laos, Myanmar, Thailand, the Thai-Myanmar border region, and Bangladesh and
presenting with acute febrile illnesses (≤ 14 days duration) to participating health
facilities.
This study is funded by the UK Wellcome Trust. The grant reference number is 215604/Z/19/Z
Description:
The majority of people in low- and middle-income countries (LMICs) in South and Southeast
Asia live in rural areas. These people are some of the poorest in the region and the exact
health issues which concern them have not been well defined, in that they have not been fully
studied. Despite this lack of data, there are indications that disease of an infectious
aetiology, 'febrile illness,' in particular in the tropics, still accounts for significant
morbidity and mortality. This is in contrast to higher-income countries.
The South and Southeast Asian Community-based Trials Network in Rural Febrile Illness project
(SEACTN RFI) aims to better understand and quantify the burden of febrile illness, the
aetiological causes and the manner in which it affects the people of the area, all on a scale
which has not been attempted before. It 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. The initial study will be observational, as
the current understanding of the local health issues and the health systems in these areas is
insufficient to know how best to intervene.
In a separate work package, Work Package A (WP-A), the investigators will be collecting data
from within the participating SEACTN communities through village health workers (VHWs) and
local health facilities on the incidence, causes and outcomes of febrile illness in these
areas.
In Work Package B (WP-B) will recruit patients seeking care at higher level facilities than
the WP-A VHWs and health centres. These patients are likely to be more severely ill, in order
to obtain a more thorough understanding of the causes and burden of febrile illness in these
areas. A broader range of specimens, including venous blood samples and respiratory specimens
will be collected. In-depth diagnostic testing including blood cultures, serological assays,
pathogen molecular diagnostics, host biomarker assays, and validation of pathogen-blind next
generation sequencing approaches will be conducted. The data from WP-A gathered in the
community complemented by the WP-B data from higher level health facilities in the same
regions will provide a rich understanding of the causes, incidence and outcomes of febrile
illness in these areas. These data will be analysed using advanced statistical methodology to
create electronic decision-support tools (eDSTs) to aid VHWs in their assessment, triage and
treatment of patients. These and other relevant interventions will later be trialled across
the SEACTN villages.