NCT04823026

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

December 28, 2022

Status Verified

December 1, 2022

Enrollment Period

1.6 years

First QC Date

March 26, 2021

Last Update Submit

December 25, 2022

Conditions

Bacterial InfectionsUrinary Tract InfectionsSepsisFeverViral InfectionInfant, Newborn, DiseaseBacteremiaMeningitis

Outcome Measures

Primary Outcomes (1)

  • Host RNA expression profiles

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

    21 months

Secondary Outcomes (2)

  • Application of known host RNA profiles

    21 months

  • Time study

    21 months

Study Arms (3)

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).

Eligibility Criteria

AgeUp to 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Young infants suspected of infection and admitted to one of the 4 paediatric departments in the Capital Region of Denmark.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Department of Paediatrics and Adolescent Medicine, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Department of Paediatrics and Adolescent Medicine, Herlev Hospital

Herlev, 2730, Denmark

Location

Department of Paediatrics and Adolescent Medicine, Nordsjællands Hospital - Hillerød

Hillerød, 3400, Denmark

Location

Department of Paediatrics, Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

All included young infants will have 0.50 - 2.50 ml whole blood drawn into PAXgene blood RNA tubes (Qiagen®) along with routine blood tests within 48 hours of admission. Host RNA expression profiling (whole transcriptome profiling) by RNA sequencing will be performed at the Centre for Genomic Medicine, Rigshospitalet.

MeSH Terms

Conditions

Bacterial InfectionsUrinary Tract InfectionsSepsisFeverVirus DiseasesDiseaseBacteremiaMeningitis

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsBody Temperature ChangesSigns and SymptomsNeuroinflammatory DiseasesNervous System Diseases

Study Officials

  • Kia Hee Schultz Dungu, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

  • Ulrikka Nygaard, Ass Prof PhD

    Rigshospitalet, Denmark

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 26, 2021

First Posted

March 30, 2021

Study Start

May 15, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

December 28, 2022

Record last verified: 2022-12

Locations

DK(4)