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

Impact of Multiplex Respiratory Pathogen Testing on Antimicrobial Consumption and Hospital Admissions at Pediatric Emergency Room: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infections
• Intervention / Treatment: Diagnostic test: QIAstat at pediatric emergency room

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.

• Study Type: Interventional
• Enrollment (Actual): 1350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Oulu, Finland, 90014
    • Department of Pediatrics, Oulu University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Point-of-care testing of respiratory pathogens on admission; 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 test: QIAstat at pediatric emergency room; Pediatric acute care nurses will obtain respiratory samples for testing from all patients with fever or any respiratory symptom.
NO_INTERVENTION: Routine ED protocol; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of children with antibiotic prescription at emergency room	Antibiotic consumption at emergency room	Up to 1 day after study entry

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of children with antibiotics in one week	Antimicrobial prescription rate	0-7 days after study entry
Proportion of children receiving macrolide antibiotic at pediatric emergency room	Among all children randomized	Up to 1 day after study entry
Proportion of infants aged < 3 months receiving macrolide antibiotic at pediatric emergency room	Among all children randomized	Up to 1 day after study entry
Proportion of children admitted to hospital	Hospital admissions	Up to 1 day after study entry
Proportion of children admitted to hospital	Hospital admissions	0-7 days after study entry
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	Up to 1 day after study entry
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	0-7 days after study entry
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	0-7 days
Number of diagnostic tests per child other than point-of-care test performed within one week	Ancillary laboratory testing	0-7 days after discharge
Proportion of children with admission to pediatric intensive care unit or intensive care unit	Admission to pediatric intensive care unit or intensive care unit	0-30 days
Proportion of children who died within one month after study entry	Mortality	0-30 days
Cost in euros per child per visits	Visit associated cost (euros)	0-7 days after study entry
Length of stay at emergency room in minutes	Mean length of visit at emergency room (minutes)	Up to 1 day after study entry
Proportion of children receiving correct pathogen directed therapy	Antimicrobial use for Mycoplasma pneumoniae, pertussis and influenza	0-7 days after study entry
Time to initiation of correct pathogen directed therapy	Antimicrobials for Mycoplasma pneumoniae, pertussis and influenza (minutes)	0-7 days after study entry

Collaborators and Investigators

• Sponsor: University of Oulu
• Collaborators: Oulu University Hospital
• Investigators: Principal Investigator: Terhi S Tapiainen, MD,PhD, Oulu University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 6, 2019
• Primary Completion (ACTUAL): March 20, 2020
• Study Completion (ACTUAL): April 13, 2020

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: April 29, 2019
• First Posted (ACTUAL): May 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Pediatrics; Antimicrobial stewardship; Anti-bacterial agents; Patient admission; Emergency room; Cost-benefit analysis; Point-of-care testing; Respiratory pathogen; Pediatric emergency medicine
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Diseases; Disease Attributes; Emergencies; Respiratory Tract Infections
• Other Study ID Numbers: EETTMK_08_2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No