Host RNA Profiles to Detect Infections in Young Infants

This study seeks to identify and test host RNA expression profiles as markers for infections in young infants. Preliminary studies have shown high sensitivity and specificity for the discrimination of bacterial from non-bacterial infections in children, but the method has only been investigated in a limited number of young infants. The study aims to include 65 young infants with serious bacterial infections. The samples will be analysed by RNA sequencing. New diagnostic tools may help reduce unnecessary antibiotic treatment, antibiotic resistance, side-effects, hospitalisation and invasive procedures.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bacterial Infections Bacteremia Bacterial Infections and Mycoses Body Temperature Changes Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fever Infant, Newborn, Disease Infections Inflammation Male Urogenital Diseases Meningitis Nervous System Diseases Neuroinflammatory Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Signs and Symptoms Systemic Inflammatory Response Syndrome Urinary Tract Infections Urogenital Diseases Urologic Diseases Viral Infection Virus Diseases

Age range

Up to 3 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Paediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark

About this study

Background:

Infections in young infants is a challenge as 1) it is often not possible to distinguish serious bacterial infection (SBI) from viral infection by clinical appearance alone, 2) a causative organism is often not identified and 3) due to relatively low sensitivity and specificity of current biomarkers. The consequence is overtreatment with antibiotics being prescribed to as many as 50% of febrile young infants presenting to emergency departments. However, the majority of these children does not have a bacterial infection. Host RNA expression profiling has shown high sensitivity and specificity for discriminating bacterial from non-bacterial infections in preliminary studies of febrile young infants.

Methods:

A prospective multicentre observational study including young infants admitted and evaluated due to suspected infection at the 4 paediatric acute care units in the Capital Region of Denmark (Rigshospitalet, Hvidovre Hospital, Herlev Hospital, Nordsjællands Hospital - Hillerød). Whole blood will be collected in PAXgene blood RNA tubes and analysed by RNA sequencing at the Centre for Genomic Medicine, Rigshospitalet. Host RNA expression profiles will be identified in a discovery cohort and the diagnostic performance will be tested in a validation cohort. A control group of healthy and afebrile young infants will be included.

Time frames:

Patient recruiting: May 15th 2020 to February 28th 2022. Sample analysis (RNA sequencing): March 1st 2022 to August 31st 2022.

Perspectives:

New molecular-based diagnostic tools complementary to conventional methods may optimise infection management in young infants by improving early diagnostics and allowing early modification of antibiotic treatment. This will reduce antibiotic resistance, side effects, unnecessary hospitalisation and invasive procedures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

age 0-3 months
admitted from home
suspected of infection
having routine blood sampling done
gestational age or corrected gestational age greater than or equal to 37+0
informed consent

Exclusion criteria

not possible to draw blood tests
withdrawal of consent
sampling >48 hours after admission

Treatment and study plan

Primary outcomes

Host RNA expression profiles

Time frame: 21 months

To identify specific host RNA expression profiles in whole blood in response to bacterial infections in young infants

Secondary outcomes

Application of known host RNA profiles

Time frame: 21 months

To test host RNA profiles published in other studies, e.g. based on the genes IFI44L and FAM89A
Time study

Time frame: 21 months

To investigate the change in host RNA expression over time during an infection period

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Acronym: CHILD_YIC

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Mar 30, 2021
Registry last updated: Dec 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed