Clinical trial NCT04823026: Host RNA Profiles to Detect Infections in Young Infants
Official title: Host RNA Profiles to Detect Infections in Young Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Infections
Urinary Tract Infections
Sepsis
Fever
Viral Infection
Infant, Newborn, Disease
Bacteremia
Meningitis
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 152
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young infants suspected of infection and admitted to one of the 4 paediatric departments in the Capital Region of Denmark.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Host RNA expression profiles
timeFrame: 21 months
Secondary outcomes:
measure: Application of known host RNA profiles
timeFrame: 21 months
measure: Time study
timeFrame: 21 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Paediatrics and Adolescent Medicine, Rigshospitalet
city: Herlev
country: Denmark
facility: Department of Paediatrics and Adolescent Medicine, Herlev Hospital
city: Hillerød
country: Denmark
facility: Department of Paediatrics and Adolescent Medicine, Nordsjællands Hospital - Hillerød
city: Hvidovre
country: Denmark
facility: Department of Paediatrics, Hvidovre Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Kia Hee Schultz Dungu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Ulrikka Nygaard, Ass Prof PhD
role: STUDY_CHAIR
References: