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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

Tracking Information
First Submitted Date March 26, 2021
First Posted Date March 30, 2021
Last Update Posted Date April 1, 2021
Actual Study Start Date May 15, 2020
Estimated Primary Completion Date February 28, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 26, 2021)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 26, 2021)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Host RNA Profiles to Detect Infections in Young Infants
Official Title Host RNA Profiles to Detect Infections in Young Infants
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
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.
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.
Condition
  • Bacterial Infections
  • Urinary Tract Infections
  • Sepsis
  • Fever
  • Viral Infection
  • Infant, Newborn, Disease
  • Bacteremia
  • Meningitis
Intervention Not Provided
Study Groups/Cohorts
  • 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).

Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 26, 2021)
170
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 28, 2022
Estimated Primary Completion Date February 28, 2022   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 3 Months   (Child)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT04823026
Other Study ID Numbers H-18065635-YIC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Kia Hee Schultz Dungu, Rigshospitalet, Denmark
Study Sponsor Rigshospitalet, Denmark
Collaborators Not Provided
Investigators
Principal Investigator: Kia Hee Schultz Dungu, MD Rigshospitalet, Denmark
Study Chair: Ulrikka Nygaard, Ass Prof PhD Rigshospitalet, Denmark
PRS Account Rigshospitalet, Denmark
Verification Date March 2021