Host RNA Profiles to Detect Infections in Young Infants
NCT ID: NCT04823026
Last Updated: 2022-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
152 participants
OBSERVATIONAL
2020-05-15
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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).
No interventions assigned to this group
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).
No interventions assigned to this group
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).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
2. withdrawal of consent
3. sampling \>48 hours after admission
3 Months
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Kia Hee Schultz Dungu
Principal investigator
Principal Investigators
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Kia Hee Schultz Dungu, MD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Ulrikka Nygaard, Ass Prof PhD
Role: STUDY_CHAIR
Rigshospitalet, Denmark
Locations
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Department of Paediatrics and Adolescent Medicine, Rigshospitalet
Copenhagen, , Denmark
Department of Paediatrics and Adolescent Medicine, Herlev Hospital
Herlev, , Denmark
Department of Paediatrics and Adolescent Medicine, Nordsjællands Hospital - Hillerød
Hillerød, , Denmark
Department of Paediatrics, Hvidovre Hospital
Hvidovre, , Denmark
Countries
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Other Identifiers
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H-18065635-YIC
Identifier Type: -
Identifier Source: org_study_id