Causes and Outcomes of Febrile Illness in Health Facilities in Rural South and Southeast Asia
ConditionAcute Febrile Illness
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age29+
SponsorUniversity of Oxford
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient and/or where relevant their parent/guardian/caretaker is willing and able to give informed consent /assent for participation in the study;
Aged > 28 days (day of birth = Day 1);
Axillary temperature at presentation (≥ 37.5°C (99.5°F) OR < 35.5°C (95.9°F)) and no more likely cause than sepsis for hypothermia OR History of fever in the 24 hours prior to presentation;
Onset of illness ≤ 14 days
Disqualifiers
Accident or trauma is the cause for the patient's presentation;
Presentation ≤ 3 days after routine immunisations
Is currently under follow-up or has been afebrile for less than 72 hours after completion of a follow-up period.
The treating healthcare worker's decision is to send the patient home following initial assessment.
Trial population
Patients residing in rural areas in Laos, Myanmar, Thailand, the Thai-Myanmar border region, and Bangladesh and presenting with acute febrile illnesses to participating health facilities
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
7,200 Participants
are grouped into 1 trial groupGroup A: Patients with an acute febrile illness
Trial outcomes
Primary outcomes
1
Prevalence of pathogens
Prevalence of a range of pathogens identified from febrile patients, analysed by region and participant age group
Time frame
Samples collected over approximately 1 monthSecondary outcomes
1
Recovery status
Recovery status e.g. full recovery, partial recovery, deterioration, and death at specified time points up to 28 days from enrolment
Time frame
Approximately 1 month2
The association between host biomarkers and other predictors with aetiological diagnoses and clinical outcomes
The area under the curve, sensitivity and specificity of host biomarkers and other predictors to identify bacterial infections and to predict severe outcomes.
Time frame
Samples collected over approximately 1 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Oxford
Lead sponsor
Shoklo Malaria Research Unit (SMRU)
Collaborator
Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit
Collaborator
Building Resources Across Communities (BRAC), Bangladesh
Collaborator
Mahidol Oxford Tropical Medicine Research Unit
Collaborator
Chiang Rai Clinical Research Unit (CCRU), Thailand
Collaborator
Source ClinicalTrials.gov