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Host RNA Profiles to Detect Infections in Young Infants (CHILD_YIC)

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ClinicalTrials.gov Identifier: NCT04823026
Recruitment Status : Recruiting
First Posted : March 30, 2021
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Kia Hee Schultz Dungu, Rigshospitalet, 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.

Condition or disease
Bacterial Infections Urinary Tract Infections Sepsis Fever Viral Infection Infant, Newborn, Disease Bacteremia Meningitis

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.

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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
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).




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. Time study [ Time Frame: 21 months ]
    To investigate the change in host RNA expression over time during an infection period


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04823026


Contacts
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Contact: Kia Hee Schultz Dungu, MD +45 22645782 kia.hee.schultz.dungu@regionh.dk
Contact: Ulrikka Nygaard, Ass Prof PhD +45 35459761 Ulrikka.Nygaard@regionh.dk

Locations
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Denmark
Department of Paediatrics and Adolescent Medicine, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Kia S Hee Schultz Dungu, MD    +45 22645782    kia.hee.schultz.dungu@regionh.dk   
Contact: Ulrikka Nygaard, MD, PhD    +4535459761    Ulrikka.Nygaard@regionh.dk   
Department of Paediatrics and Adolescent Medicine, Herlev Hospital Recruiting
Herlev, Denmark, 2730
Contact: Lisbeth Samsø Schmidt, MD, PhD       lisbeth.samsoe.schmidt@regionh.dk   
Department of Paediatrics and Adolescent Medicine, Nordsjællands Hospital - Hillerød Recruiting
Hillerød, Denmark, 3400
Contact: Jonathan Peter Glenthøj, MD, PhD       jonathan.peter.glenthoej.01@regionh.dk   
Contact: Inger Merete Jørgensen, MD, PhD       inger.merete.joergensen@regionh.dk   
Department of Paediatrics, Hvidovre Hospital Recruiting
Hvidovre, Denmark, 2650
Contact: Dina Cortes, Professor       Dina.Cortes@regionh.dk   
Contact: Allan Bybeck Nielsen, MD       Allan.Bybeck.Nielsen@regionh.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Kia Hee Schultz Dungu, MD Rigshospitalet, Denmark
Study Chair: Ulrikka Nygaard, Ass Prof PhD Rigshospitalet, Denmark
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Responsible Party: Kia Hee Schultz Dungu, Principal investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT04823026    
Other Study ID Numbers: H-18065635-YIC
First Posted: March 30, 2021    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Bacterial Infections
Bacteremia
Virus Diseases
Meningitis
Infant, Newborn, Diseases
Urologic Diseases
Central Nervous System Diseases
Nervous System Diseases
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes