CHILD_YIC: Host RNA Profiles to Detect Infections in Young Infants

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Recruiting
CT.gov ID
NCT04823026
Collaborator
(none)
170
4
21.5
42.5
2

Study Details

Study Description

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
170 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Host RNA Profiles to Detect Infections in Young Infants
Actual Study Start Date :
May 15, 2020
Anticipated Primary Completion Date :
Feb 28, 2022
Anticipated Study Completion Date :
Feb 28, 2022

Arms and Interventions

Arm Intervention/Treatment
Group 1

70 young infants with proven bacterial infection. Interventions: Diagnostic test: Host RNA expression profiling (whole transcriptome profiling) using whole blood RNA sequencing. Cases will be randomly assigned to a "Discovery Cohort" (identification of diagnostic RNA profiles) or a "Validation Cohort" (validation of the identified RNA profiles).

Group 2

70 young infants with non-bacterial infection. Interventions: Diagnostic test: Host RNA expression profiling (whole transcriptome profiling) using whole blood RNA sequencing. Cases will be randomly assigned to a "Discovery Cohort" (identification of diagnostic RNA profiles) or a "Validation Cohort" (validation of the identified RNA profiles).

Group 3

30 young infants without infection. Interventions: Diagnostic test: Host RNA expression profiling (whole transcriptome profiling) using whole blood RNA sequencing. Cases will be randomly assigned to a "Discovery Cohort" (identification of diagnostic RNA profiles) or a "Validation Cohort" (validation of the identified RNA profiles).

Outcome Measures

Primary Outcome Measures

  1. Host RNA expression profiles [21 months]

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

Secondary Outcome Measures

  1. Application of known host RNA profiles [21 months]

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

  2. Time study [21 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 3 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. age 0-3 months

  2. admitted from home

  3. suspected of infection

  4. having routine blood sampling done

  5. gestational age or corrected gestational age greater than or equal to 37+0

  6. informed consent

Exclusion Criteria:
  1. not possible to draw blood tests

  2. withdrawal of consent

  3. sampling >48 hours after admission

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Paediatrics and Adolescent Medicine, Rigshospitalet Copenhagen Denmark 2100
2 Department of Paediatrics and Adolescent Medicine, Herlev Hospital Herlev Denmark 2730
3 Department of Paediatrics and Adolescent Medicine, Nordsjællands Hospital - Hillerød Hillerød Denmark 3400
4 Department of Paediatrics, Hvidovre Hospital Hvidovre Denmark 2650

Sponsors and Collaborators

  • Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Kia Hee Schultz Dungu, MD, Rigshospitalet, Denmark
  • Study Chair: Ulrikka Nygaard, Ass Prof PhD, Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kia Hee Schultz Dungu, Principal investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT04823026
Other Study ID Numbers:
  • H-18065635-YIC
First Posted:
Mar 30, 2021
Last Update Posted:
Apr 1, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 1, 2021