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Recruiting NCT04629053

NCT04629053 Causes and Outcomes of Febrile Illness in Health Facilities in Rural South and Southeast Asia

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Clinical Trial Summary
NCT ID NCT04629053
Status Recruiting
Phase
Sponsor University of Oxford
Condition Acute Febrile Illness
Study Type OBSERVATIONAL
Enrollment 7,200 participants
Start Date 2022-06-21
Primary Completion 2026-12-01

Trial Parameters

Condition Acute Febrile Illness
Sponsor University of Oxford
Study Type OBSERVATIONAL
Phase N/A
Enrollment 7,200
Sex ALL
Min Age 29 Days
Max Age N/A
Start Date 2022-06-21
Completion 2026-12-01

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Brief 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

Eligibility Criteria

Inclusion Criteria: 1. The patient and/or where relevant their parent/guardian/caretaker is willing and able to give informed consent /assent for participation in the study; 2. Aged \> 28 days (day of birth = Day 1); 3. 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; 4. Onset of illness ≤ 14 days Exclusion Criteria: 1. Accident or trauma is the cause for the patient's presentation; 2. Presentation ≤ 3 days after routine immunisations 3. Is currently under follow-up or has been afebrile for less than 72 hours after completion of a follow-up period. 4. The treating healthcare worker's decision is to send the patient home following initial assessment.

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