A Rapid Triage Test to Improve Risk-stratification of Febrile Children (EChiLiBRiST, Clinical Trial 1, Outpatients)

Launched by BARCELONA INSTITUTE FOR GLOBAL HEALTH · May 17, 2024

Keywords

ClinConnect Summary

This clinical trial, called EChiLiBRiST, is designed to improve how doctors assess children with fever to better identify those who might be at risk for serious infections. The study will test a new method that combines a specific blood test with existing guidelines for evaluating sick children. By doing this, researchers hope to make it easier for healthcare providers to decide whether a child should be admitted to the hospital, referred to a specialist, or sent home safely.

To participate in the trial, children must be between 2 months and 5 years old, have a fever lasting no more than 7 days, or show signs of severe infection. Parents or caregivers will need to provide written consent for their child's involvement, and families should live in the area where the study is taking place. While the trial is not yet recruiting participants, it aims to ultimately improve health outcomes for children suffering from febrile illnesses in sub-Saharan Africa.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥2 months and \<60 months
• • Written informed consent from the child's parent or caregiver
• • History of fever for ≤7 days OR hypothermia (i.e., axillary temperature \<35.5ºC) OR suspected severe infection (e.g., in children with moderate or severe acute malnutrition).
• • Lives within the catchment area of the study facility and must intend to continue to reside there for the duration of the study
• • For the RTI sub-study only: presence of respiratory symptoms compatible with RTI.
• Exclusion Criteria:
• • Weight less than 2.5kg
• • Main reason for consultation is an injury, trauma or acute poisoning
• • Enrolled in another clinical trial testing a new drug
• • Enrolled in a vaccine trial in the last 3 months.
• • Any other condition determined by the investigators that makes it unlikely that the participant would complete the study