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Point-of-care Testing of Respiratory Pathogens at Pediatric Emergency Room (Hevi-RCT)

Primary Purpose

Respiratory Tract Infections

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
QIAstat at pediatric emergency room
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Respiratory Tract Infections focused on measuring Anti-bacterial agents, Emergency room, Respiratory pathogen, Point-of-care testing, Patient admission, Pediatrics, Pediatric emergency medicine, Cost-benefit analysis, Antimicrobial stewardship

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Any respiratory symptom defined as tachypnea, shortness of breath, apnea, wheezing, cough, rhinitis, croup, sneezing, ear ache, or sore throat AND/OR
  • Fever > 38.0 C

Exclusion Criteria:

  • Need of resuscitation at emergency room
  • Need of immediate transfer to pediatric intensive care unit

Sites / Locations

  • Department of Pediatrics, Oulu University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Point-of-care testing of respiratory pathogens on admission

Routine ED protocol

Arm Description

Point-of-care testing of respiratory pathogens on admission. The subjects will receive the point-of-care testing of respiratory pathogens at pediatric emergency room. The results are ready within 1 one hour.

Diagnostic tests for respiratory pathogens will be obtained according to clinical judgement and tested on microbiological laboratory. The results are ready on the next office day.

Outcomes

Primary Outcome Measures

Proportion of children with antibiotic prescription at emergency room
Antibiotic consumption at emergency room

Secondary Outcome Measures

Proportion of children with antibiotics in one week
Antimicrobial prescription rate
Proportion of children receiving macrolide antibiotic at pediatric emergency room
Among all children randomized
Proportion of infants aged < 3 months receiving macrolide antibiotic at pediatric emergency room
Among all children randomized
Proportion of children admitted to hospital
Hospital admissions
Proportion of children admitted to hospital
Hospital admissions
Number of other diagnostic tests than point-of-care test performed at emergency room
Number and cost of diagnostic tests such as blood culture, blood chemistry
Proportion of children with readmission to hospital or revisit at emergency room
Proportion of children with hospital readmission or emergency room revisit within 7 days after discharge from ED or hospital
Proportion of children with outpatient telephone contact within 7 days after discharge from emergency room
Outpatient telephone contact within 7 days after discharge from emergency room
Number of diagnostic tests per child other than point-of-care test performed within one week
Ancillary laboratory testing
Proportion of children with admission to pediatric intensive care unit or intensive care unit
Admission to pediatric intensive care unit or intensive care unit
Proportion of children who died within one month after study entry
Mortality
Cost in euros per child per visits
Visit associated cost (euros)
Length of stay at emergency room in minutes
Mean length of visit at emergency room (minutes)
Proportion of children receiving correct pathogen directed therapy
Antimicrobial use for Mycoplasma pneumoniae, pertussis and influenza
Time to initiation of correct pathogen directed therapy
Antimicrobials for Mycoplasma pneumoniae, pertussis and influenza (minutes)

Full Information

First Posted
April 23, 2019
Last Updated
November 3, 2020
Sponsor
University of Oulu
Collaborators
Oulu University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03932942
Brief Title
Point-of-care Testing of Respiratory Pathogens at Pediatric Emergency Room
Acronym
Hevi-RCT
Official Title
Impact of Multiplex Respiratory Pathogen Testing on Antimicrobial Consumption and Hospital Admissions at Pediatric Emergency Room: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 6, 2019 (Actual)
Primary Completion Date
March 20, 2020 (Actual)
Study Completion Date
April 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oulu
Collaborators
Oulu University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main objective of the trial is to evaluate the effect of point-of-care testing of respiratory pathogens at a pediatric emergency room on the antibiotic consumption and hospital admissions in acutely ill children.
Detailed Description
The study is a randomized controlled trial including children 0 up to 17 years of age with fever or acute respiratory infection at a pediatric emergency department in university hospital. In total 1668 subjects will be randomly allocated to undergo point-of-care multiplex respiratory pathogen testing with results ready within approximately one hour or to a control group with testing according to clinical judgement and results ready within next office day. Subjects will be randomized on admission and unequal allocation ratio of 2:1 (1112 subjects to intervention and 556 subjects to control arm) will be used. Data on rate of hospitalization, antibiotic prescriptions, ancillary testing and length of visit will be collected using medical record system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Infections
Keywords
Anti-bacterial agents, Emergency room, Respiratory pathogen, Point-of-care testing, Patient admission, Pediatrics, Pediatric emergency medicine, Cost-benefit analysis, Antimicrobial stewardship

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial 2:1
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Point-of-care testing of respiratory pathogens on admission
Arm Type
Experimental
Arm Description
Point-of-care testing of respiratory pathogens on admission. The subjects will receive the point-of-care testing of respiratory pathogens at pediatric emergency room. The results are ready within 1 one hour.
Arm Title
Routine ED protocol
Arm Type
No Intervention
Arm Description
Diagnostic tests for respiratory pathogens will be obtained according to clinical judgement and tested on microbiological laboratory. The results are ready on the next office day.
Intervention Type
Diagnostic Test
Intervention Name(s)
QIAstat at pediatric emergency room
Intervention Description
Pediatric acute care nurses will obtain respiratory samples for testing from all patients with fever or any respiratory symptom.
Primary Outcome Measure Information:
Title
Proportion of children with antibiotic prescription at emergency room
Description
Antibiotic consumption at emergency room
Time Frame
Up to 1 day after study entry
Secondary Outcome Measure Information:
Title
Proportion of children with antibiotics in one week
Description
Antimicrobial prescription rate
Time Frame
0-7 days after study entry
Title
Proportion of children receiving macrolide antibiotic at pediatric emergency room
Description
Among all children randomized
Time Frame
Up to 1 day after study entry
Title
Proportion of infants aged < 3 months receiving macrolide antibiotic at pediatric emergency room
Description
Among all children randomized
Time Frame
Up to 1 day after study entry
Title
Proportion of children admitted to hospital
Description
Hospital admissions
Time Frame
Up to 1 day after study entry
Title
Proportion of children admitted to hospital
Description
Hospital admissions
Time Frame
0-7 days after study entry
Title
Number of other diagnostic tests than point-of-care test performed at emergency room
Description
Number and cost of diagnostic tests such as blood culture, blood chemistry
Time Frame
Up to 1 day after study entry
Title
Proportion of children with readmission to hospital or revisit at emergency room
Description
Proportion of children with hospital readmission or emergency room revisit within 7 days after discharge from ED or hospital
Time Frame
0-7 days after study entry
Title
Proportion of children with outpatient telephone contact within 7 days after discharge from emergency room
Description
Outpatient telephone contact within 7 days after discharge from emergency room
Time Frame
0-7 days
Title
Number of diagnostic tests per child other than point-of-care test performed within one week
Description
Ancillary laboratory testing
Time Frame
0-7 days after discharge
Title
Proportion of children with admission to pediatric intensive care unit or intensive care unit
Description
Admission to pediatric intensive care unit or intensive care unit
Time Frame
0-30 days
Title
Proportion of children who died within one month after study entry
Description
Mortality
Time Frame
0-30 days
Title
Cost in euros per child per visits
Description
Visit associated cost (euros)
Time Frame
0-7 days after study entry
Title
Length of stay at emergency room in minutes
Description
Mean length of visit at emergency room (minutes)
Time Frame
Up to 1 day after study entry
Title
Proportion of children receiving correct pathogen directed therapy
Description
Antimicrobial use for Mycoplasma pneumoniae, pertussis and influenza
Time Frame
0-7 days after study entry
Title
Time to initiation of correct pathogen directed therapy
Description
Antimicrobials for Mycoplasma pneumoniae, pertussis and influenza (minutes)
Time Frame
0-7 days after study entry

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any respiratory symptom defined as tachypnea, shortness of breath, apnea, wheezing, cough, rhinitis, croup, sneezing, ear ache, or sore throat AND/OR Fever > 38.0 C Exclusion Criteria: Need of resuscitation at emergency room Need of immediate transfer to pediatric intensive care unit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terhi S Tapiainen, MD,PhD
Organizational Affiliation
Oulu University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics, Oulu University Hospital
City
Oulu
ZIP/Postal Code
90014
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized data will be shared according to the practice in place at the time of the study completion.
IPD Sharing Time Frame
At the study completion or at submission
IPD Sharing Access Criteria
For reviewers and editors before publishing and after publishing for the whole research community
Citations:
PubMed Identifier
35679047
Citation
Mattila S, Paalanne N, Honkila M, Pokka T, Tapiainen T. Effect of Point-of-Care Testing for Respiratory Pathogens on Antibiotic Use in Children: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jun 1;5(6):e2216162. doi: 10.1001/jamanetworkopen.2022.16162.
Results Reference
derived

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Point-of-care Testing of Respiratory Pathogens at Pediatric Emergency Room

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