Status:

COMPLETED

Prediction of Disease Severity in Young Children Presenting With Acute Febrile Illness in Resource-limited Settings

Lead Sponsor:

Medecins Sans Frontieres, Spain

Collaborating Sponsors:

Mahidol Oxford Tropical Medicine Research Unit

Gadjah Mada University

Conditions:

Sepsis

Eligibility:

All Genders

28-5 years

Brief Summary

Note that this is a study that is co-sponsored by Medecins Sans Frontieres, Spain, and the University of Oxford. The primary objective is to develop a risk prediction algorithm, combining measurement...

Detailed Description

Background Febrile illnesses are amongst the most common reasons that parents seek non-routine healthcare for their children and a proportion progress to severe disease with substantial risk of morta...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • The participant may enter the study if ALL of the following apply:
  • Caretaker is willing and able to give informed consent for participation in the study;
  • Aged \> 28 days and \< 5 years \[day of birth = Day 1\];
  • Axillary temperature at presentation ≥ 37.5°C OR axillary temperature at presentation \< 35.5°C OR history of fever in last 24h;
  • Onset of illness ≤ two weeks.
  • Exclusion Criteria
  • The participant may not enter the study if ANY of the following apply:
  • Accident or trauma is the cause for child's presentation;
  • Presentation ≤ 72 hours after routine immunisations;
  • Known chronic medical condition including immunosuppression (for example, oncological conditions, HIV infection, thalassaemia, current steroid use), active chronic infection (for example, tuberculosis, hepatitis B virus), active cardiorespiratory conditions (for example, symptomatic or currently medicated congenital heart disease, cardiomyopathy or bronchiectasis);
  • Admission to any health facility during the current illness;
  • Previously enrolled in the study for a different acute illness;
  • Receipt of \> 15 minutes of inpatient treatment.

Exclusion

    Key Trial Info

    Start Date :

    March 5 2020

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    November 30 2022

    Estimated Enrollment :

    3433 Patients enrolled

    Trial Details

    Trial ID

    NCT04285021

    Start Date

    March 5 2020

    End Date

    November 30 2022

    Last Update

    April 24 2023

    Active Locations (6)

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    Page 1 of 2 (6 locations)

    1

    MSF Goyalmara Green Roof Hospital

    Cox’s Bāzār, Bangladesh

    2

    Angkor Hospital for Children

    Siem Reap, Krong Siem Reap, Cambodia

    3

    Rumah Sakit Umum Daerah Wates

    Yogyakarta, DI Yogyakarta, Indonesia

    4

    Laos-Oxford-Mahosot Wellcome Trust Research Unit

    Vientiane, Laos