Biomarkers of Mortality and Morbidity in Children Hospitalized With Fever

NCT04726826 | Completed

• 1 other identifier: Pro00106489
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to identify clinically informative biomarkers of host defense pathways with potential utility as diagnostic and prognostic tools among children hospitalized with acute febrile illness in a resource-constrained sub-Saharan African setting. The working hypothesis is that a panel of biomarkers, readily measurable from a peripheral blood sample, may serve as a clinically useful instrument to distinguish between common pediatric causes of fever, predict those children at greatest need of aggressive supportive care and/or adjunctive therapies, and identify those children at greatest risk of mortality. The use of objective and quantitative tools may facilitate the triage and clinical care of febrile children admitted to hospital in the sub-Saharan African context.

Conditions

Fever

Keywords

fever; child; biomarker

Outcome Measures

Primary Outcomes (1)

• Mortality

  in-hospital mortality

  through study completion, an average of 1 week

Secondary Outcomes (3)

• Hospital length of stay

  through study completion, an average of 1 week

• Lambarene organ dysfunction score (LODS), a composite clinical severity score

  evaluated at admission

• Signs of Inflammation in Children that Kill (SICK), a composite clinical severity score

  evaluated at admission

Interventions

Diagnostic and prognostic biomarkers DIAGNOSTIC_TEST

Observational study of biomarkers predictive of morbidity and mortality in febrile children

Eligibility Criteria

• Age: 2 Months - 5 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The choice of the age range for this study is as follows. Children under 5 represent a vulnerable group, in whom infectious diseases play a major role as contributors to overall mortality. Children under 2 months of age (the neonatal group) represent a unique population with different infectious risks and are therefore outside the scope of our current study. The reason for exclusion of isolated diarrheal illness is that dehydration, acidosis and electrolyte imbalances are the proximal causes of mortality, rather than activation of host defense pathways with excessive inflammation and endothelial activation. Host biomarkers are therefore not expected to predict mortality with the same accuracy in diarrhea syndromes.

You may qualify if:

• Age 2 months to 5 years
• History of fever within past 48 hours or axillary temperature \>37.5°C
• Hospital admission warranted based on clinician judgment
• Consent to blood sampling and data collection

You may not qualify if:

• Outside eligible age range
• No history or objective evidence of fever
• Diarrheal illness without other symptoms
• Outpatient management
• Denial of consent to participate in study

Sponsors & Collaborators

• University of Alberta: lead
• University of Toronto: collaborator
• Global Health Uganda LTD: collaborator

Study Sites (1)

Jinja Regional Referral Hospital

Jinja, Uganda

Location

Related Publications (1)

• McDonald CR, Leligdowicz A, Conroy AL, Weckman AM, Richard-Greenblatt M, Ngai M, Erice C, Zhong K, Namasopo S, Opoka RO, Hawkes MT, Kain KC. Immune and endothelial activation markers and risk stratification of childhood pneumonia in Uganda: A secondary analysis of a prospective cohort study. PLoS Med. 2022 Jul 13;19(7):e1004057. doi: 10.1371/journal.pmed.1004057. eCollection 2022 Jul.

  PMID: 35830474 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma obtained by venipuncture at hospital admission

MeSH Terms

Conditions

Fever

Interventions

Diagnosis

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael T Hawkes, MD, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 27, 2021
• Study Start: February 1, 2012
• Primary Completion: September 15, 2013
• Study Completion: September 15, 2013
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 10 years
• Access Criteria: Upon reasonable request to study principal investigator.

Locations

UG (1)