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

NCT04285021 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3433

Last updated 2023-04-24

No results posted yet for this study

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 measurements of host biomarkers and clinical features at the point-of-triage, for children with an acute febrile illness in resource-limited settings.

The secondary objectives are to determine which host biomarkers, feasible for measurement at the point-of-care, are predictive of disease severity. Additionally to determine the optimal combination of clinical features (including demographics, anthropometric data, historical variables, vital signs, clinical signs and clinical symptoms), feasible for assessment by limited-skill health workers, that is predictive of disease severity.

The tertiary objectives are to explore the impact of different methods of outcome classification on development of the risk prediction algorithm, and to explore the performance of the algorithm to predict disease severity in key presenting clinical syndromes and aetiologies.

Conditions

Sponsors & Collaborators

  • Mahidol Oxford Tropical Medicine Research Unit

    collaborator OTHER
  • Gadjah Mada University

    collaborator OTHER
  • Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit

    collaborator OTHER
  • Cambodia Oxford Medical Research Unit

    collaborator UNKNOWN
  • University of Medicine and Pharmacy at Ho Chi Minh City

    collaborator OTHER
  • Research Institute for Tropical Medicine, Philippines

    collaborator OTHER_GOV
  • International Centre for Diarrhoeal Disease Research, Bangladesh

    collaborator OTHER
  • Hanoi Medical University

    collaborator OTHER
  • Medecins Sans Frontieres, Spain

    lead OTHER

Principal Investigators

  • Sakib Burza, PhD · Medecins Sans Frontieres, Spain

  • Yoel Lubell, PhD · Mahidol Oxford Tropical Medicine Research Unit

Eligibility

Min Age
28 Days
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-05
Primary Completion
2022-11-30
Completion
2022-11-30

Countries

  • Bangladesh
  • Cambodia
  • Indonesia
  • Laos
  • Vietnam

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04285021 on ClinicalTrials.gov